FDA Registration
Active
🇺🇸 United States
Nalge Nunc International Corporation
Reg #: 1314344
·
FEI: 1000087290
·
Expires 2026
Products
6
Proprietary Names
110
Establishment Types
4
Classifications
6
Registration Details
- Registration Name
- Nalge Nunc International Corporation
- Registration Number
- 1314344
- FEI Number
- 1000087290
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 75 Panorama Creek Dr
- City
- Rochester
- State
- NY
- ZIP
- 14625
- Country
- US
Owner / Operator
- Firm Name
- Thermo Fisher Scientific
- Operator Number
- 2517925
- Address
- 168 Third Avenue, --
- City
- Waltham
- State
- MA
- Postal Code
- 02451
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Container, Specimen Mailer And Storage, Temperature Controlled, Non-Sterile | NNL | Class 1 | Pathology | No | 2004-03-26 |
| Labware, Assisted Reproduction, Exempt | PUD | Class 2 | Obstetrics/Gynecology | No | 2018-12-24 |
| Micro Pipette | JRC | Class 1 | Clinical Chemistry | No | 2006-09-12 |
| Container, Specimen, Sterile | FMH | Class 1 | Pathology | No | 2001-08-27 |
| Device, Gas Generating | KZJ | Class 1 | Microbiology | No | 2015-08-25 |
| Container, Specimen, Non-Sterile | NNI | Class 1 | Pathology | No | 2006-11-13 |
Proprietary Names
Thermo Scientific ALERELABS SPLT FOILTP KT 50/CS (90675)
Thermo Scientific ALERELABS SGL FOILTOP KT 50/CS (90674)
NuncTM IVF MultiDish 4-Welll, Nunclon (144444)
NuncTM IVF ICSI Dish (150265)
NuncTM IVF Dishes (35mm), Nontreated (150255)
NuncTM IVF Center Well Dish (150260)
NuncTM IVF Dishes (90mm), Nontreated (150360)
NuncTM IVF MultiDish 4-Well, Nontreated (179830)
NuncTM IVF Dishes (60mm), Nontreated (150270)
Fisherbrand Transfer Pipette, 5mL (Cat. No. 13-711-5AMMD)
Fisherbrand Transfer Pipette, 4.9mL (Cat. No. 13-711-336MD)
Fisherbrand Transfer Pipette, 5.8mL (Cat. No. 13-711-9AMMD)
Fisherbrand Transfer Pipette, 4.8mL (Cat. No. 13-711-274MD)
Fisherbrand Transfer Pipette, 7.7mL (Cat. No. 13-711-7MMD)
Nunc Universal Tri-coded Tubes 1.8mL Ext Sharp V-bottom Bulk (374506-WP1D)
Samco Bio-Tite Wide Mouth, ST 120mL, 53mm, no lab, ORG Cap (07 0000)
Samco Bio-Tite Narrow Mouth, ST 90mL, 48mm, w/lab, ORG Cap, dsp box (02 0214)
Samco Bio-Tite Wide Mouth, ST 120mL, 53mm, w/lab, ORG Cap (01 0001)
Samco Clicktainer Vials, ST, 120mL, 53mm, w/lab, WHT Cap (120WHT53-1000)
Samco Clicktainer Vials, ST, 120mL, 53mm, O/R Pouch, WHT Cap (120WHT53-4000)
Nunc CryoTube, 3.6mL, sterile, internal thread, round (366524)
Nunc CryoTube, 1.8mL, sterile, internal thread, round (368632)
Samco Bio-Tite, 90mL, Midstream Kit with Funnel (07 0010)
Nunc CryoTube, 4.5mL, sterile, internal thread, starfoot, round (379146)
Samco Bio-Tite Narrow Mouth, ST 60mL, 48mm, w/lab, ORG Cap (03 0006)
Nunc CryoTube, 4.5mL, sterile, internal thread, round (363452)
Samco Bio-Tite Wide Mouth, ST 90mL, 53mm, w/lab, Natural Cap (021038)
Nunc CryoTube, 1mL, internal thread, Green Band, PP/PP, sterile (377738)
Samco Bio-Tite Narrow Mouth, ST 60mL, 48mm, w/lab, WHT Cap (03 0007)
Samco Bio-Tite Narrow Mouth, ST 90mL, 48mm, w/lab, ORG Cap (02 0016)
Samco Bio-Tite Wide Mouth, ST 120mL, 53mm, w/lab, NAT Cap (010038)
Samco Bio-Tite, ST, 120mL, 53mm, BLU Cap (07 0006)
Samco Bio-Tite, ST, 90mL, 48mm Midstream Kit with Funnel (07 0001)
Samco Clicktainer Vial, ST, 90mL, 53mm, w/lab, GRN Cap (90GRN53-1000)
Samco Bio-Tite Wide Mouth, ST 90mL, 53mm, w/lab, Natural Cap (02 1038)
Nalgene Cryogenic Tube, 2 mL externally-threaded (Cat. No. 5000-0020)
Nunc CryoTube, 1mL, sterile, internal thread, foot, conical (366656)
Samco Clicktainer Vial, ST, 90mL, 53mm, w/temp strip, WHT Cap (90WHT53-1002)
Samco Bio-Tite Narrow Mouth, ST 60mL, 48mm, w/lab, Green Cap (03 0008)
Samco Bio-Tite Wide Mouth, ST 120mL, 53mm, w/lab, NAT Cap (01 0038)
Nalgene Cryogenic Tube, 5 mL externally-threaded (5000-0050)
Nunc Universal Tri-coded Tubes 1.8mL Ext Sharp V-bottom Bulk (SP374506-WP1D)
Nunc CryoTube, 3.6mL, sterile, internal thread, starfoot, round (379189)
Nunc CryoTube, 1mL, sterile, internal thread, starfoot, conical (377224)
Samco Bio-Tite, ST, 120mL, 53mm Midstream Kit No Funnel (07 0002)
Samco Clicktainer Vials, ST, 120mL, 53mm, Midstream Kit, no fnl (120WHT53-3000)
Samco Clicktainer Vials, ST, 120mL, 53mm, O/R Pouch, ORG Cap (120ORG53-4000)
Fisherbrand 60mL, 48mm, ST, w/lab and temp strip, WHT Cap (22 610 131)
Samco Bio-Tite Wide Mouth, ST 90mL, 53mm, w/lab, WHT Cap (02 1016)
Samco Bio-Tite, 120ml, Midstream Kit, no funnel (07 0020)
Samco Bio-Tite Wide Mouth, ST, 90mL, 53mm, w/lab, YEL Cap (22-2090)
Samco Bio-Tite Narrow Mouth, ST 90mL, 48mm, w/lab, Natural Cap (02 0038)
Samco Clicktainer Vials, ST, 120mL, 53mm, w/lab, ORG Cap (120ORG53-1000)
Nunc CryoTube, 1.8mL, sterile, internal thread, round (363401)
Nalgene Specimen Cryogenic Vial, 15 mL externally-threaded (Cat. No. 5005-0015)
Samco Bio-Tite Narrow Mouth, ST 90mL, 48mm, w/lab, WHT Cap (02 0039)
Samco Bio-Tite Wide Mouth, ST 90mL, 53mm, w/lab, ORG Cap (02 1090)
Nunc CryoTube, 1.8mL, sterile, internal thread, starfoot, round (377267)
Samco Clicktainer Vial, WHT Cap, 90mL, 53mm, w/lab, temp strip, ST (90WHT53-1001)
Samco Clicktainer Vial, ST, 90mL, 53mm, w/lab, WHT Cap (90WHT53-1000)
Samco Clicktainer Vial, ST, 90mL, 53mm, w/lab, ORG Cap (90ORG53-1000)
Samco Clicktainer Vial, ST, 90mL, 53mm, w/lab, ORG Cap, dsp box (90ORG53-1001)
Nunc Universal Tube, 2 mL internally-threaded (Cat. No. 374512)
2500ML 24 HR URINE CONTAINER (Cat. No. U3010-1)
Samco Bio-Tite Wide Mouth, NS 90mL, 53mm, w/lab, WHT Cap (Cat. No. 02 1102)
Samco Bio-Tite Wide Mouth, NS 90mL, 53mm, no lab, WHT Cap (Cat. No. 02 1181)
Samco Bio-Tite Narrow Mouth, NS 90mL, 48mm, w/lab, YEL Cap, non-tab (Cat. No. 02 0148)
Samco Bio-Tite Wide Mouth, NS 120mL, 53mm, w/lab, YEL Cap (Cat. No. 01 0100)
Samco Bio-Tite Wide Mouth, NS 90mL, 53mm, w/lab, WHT Cap (Cat. No. 02 1106)
Samco UrineGUARD Container 3500mL, 24hr (Cat. No. 30 3500)
Samco Clicktainer Vial, NS, 90mL, 53mm, no lab, WHT Cap (Cat. No. 90WHT53-2003)
Samco Bio-Tite Wide Mouth, NS 120mL, 53mm, no lab, RED Cap, bulk (Cat. No. 01 0182)
Fisherbrand 60mL, 48mm, NS, w/lab and tem strip, WHT Cap (Cat. No. 22 610 130)
Samco UrineGUARD Container 3000mL (bilingual sticker inst) (Cat. No. 30 3000L)
Samco Clicktainer Vial, NS, 90mL, 53mm, w/temp strip, WHT Cap (Cat. No. 90WHT53-2004)
3000ML 24 HR URINE CONTAINER (Cat. No. U3010-3)
Samco Bio-Tite Narrow Mouth, NS 90mL, 48mm, no lab, YEL Cap (Cat. No. 02 0147)
Samco UrineGUARD Container 3000mL, 24hr (Cat. No. 30 3000)
Samco Bio-Tite Narrow Mouth, NS 60ml, 48mm, no lab, YEL Cap (Cat. No. 03 0193)
Samco Bio-Tite Narrow Mouth, NS 90mL, 48mm, WHT Cap (Cat. No. 02 0140)
Samco Bio-Tite, NS, 20ml, 35mm, no lab, WHT Cap (Cat. No. 06 0181)
Samco Bio-Tite Narrow Mouth, NS 90mL, 48mm, YEL Cap (Cat. No. 02 0146)
Samco Bio-Tite Narrow Mouth, NS 60ml, 48mm, Black Cap (Cat. No. 03 0060)
3500ML 24 HR URINE CONTAINER (Cat. No. U3010-2)
Samco Bio-Tite Wide Mouth, NS 120mL, 53mm, no lab, NAT Cap, bulk (Cat. No. 01 0180)
Samco Bio-Tite Wide Mouth, NS 120mL, 53mm, no lab, ORG Cap, bulk (Cat. No. 01 0195)
Samco Clicktainer Vial, NS, 90mL, 53mm, w/lab, WHT Cap (Cat. No. 90WHT53-2000)
FISHER 24 HR URINE CONTAINER (Cat. No. 14-375-248)
Samco Clicktainer Vials, NS, 120ml, 53mm, with label, ORG Cap (Cat. No. 120ORG53-2000)
Samco Bio-Tite Wide Mouth, NS 90mL, 53mm, w/lab, YEL Cap (Cat. No. 02 1105)
Samco Clicktainer Vial, NS, WHT, 90mL, 53mm, no lab, Cap/vial sep (Cat. No. 90WHT53-2002)
Samco Bio-Tite Wide Mouth, NS 120mL, 53mm, no lab, BLU Cap (Cat. No. 01 0197)
Samco Bio-Tite Narrow Mouth, NS 40ml, 48mm, w/lab, YEL Cap (Cat. No. 04 0506)
Samco Bio-Tite Wide Mouth, NS 120mL, 53mm, no lab, WHT Cap (Cat. No. 01 0181)
3000ML 24 HR URINE CONTAINER (Cat. No. U3010-3B)
Samco Bio-Tite Wide Mouth, NS 90mL, 53mm, w/lab, Natural Cap (Cat. No. 02 1104)
Samco UrineGUARD Container 2500mL, 24hr (Cat. No. 30 2500)
Samco Bio-Tite Wide Mouth, NS 120mL, 53mm, w/lab, WHT Cap (Cat. No. 01 0101)
Samco Bio-Tite Narrow Mouth, NS 60ml, 48mm, no lab, WHT Cap (Cat. No. 03 0181)
Samco Bio-Tite Narrow Mouth, NS 40ml, 48mm, no lab , WHT Cap (Cat. No. 04 0181)
Samco Bio-Tite Wide Mouth, NS 120mL, 53mm, no lab, RED Cap (Cat. No. 01 0196)
Samco Clicktainer Vial, WHT Cap, 90mL, 53mm, w/lab, temp strip, NS (Cat. No. 90WHT53-2001)
Andwin Scientific Specimen Cup, 90mL, 53mm, NAT Cap, NS (Cat. No. 840100)
Samco Bio-Tite Narrow Mouth, NS 90mL, 48mm, no lab, YEL Cap (Cat. No. 02 0516)
Samco Bio-Tite Wide Mouth, NS 120mL, 53mm, no lab, BLU Cap, bulk (Cat. No. 01 0183)
Samco Bio-Tite Wide Mouth, NS 90mL, 53mm, no lab, Natural Cap (Cat. No. 02 1140)
Samco Bio-Tite Wide Mouth, NS, 90mL, 53mm, no lab, WHT Cap (Cat. No. 02 0180)
Samco Bio-Tite Narrow Mouth, NS 60mL, 48mm, no lab, ORG Label (Cat. No. 03 0195)
Samco Clicktainer Vials, NS, 120mL, 53mm, with label, WHT Cap (Cat. No. 120WHT53-2000)
Samco Bio-Tite Wide Mouth, NS 120mL, 53mm, no lab, Green Cap (Cat. No. 01 0198)
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility