FDA UDI
In Commercial Distribution
🇺🇸 United States
Samco™ Bio-Tite™ Narrow Mouth, ST 90mL, 48mm, w/lab, Natural Cap
DI: 10850016060447
·
Model: 020038
·
Nalge Nunc International Corporation
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
75
Basic Information
- Brand Name
- Samco™ Bio-Tite™ Narrow Mouth, ST 90mL, 48mm, w/lab, Natural Cap
- Primary DI
- 10850016060447
- Version / Model
- 020038
- Company Name
- Nalge Nunc International Corporation
- Labeler DUNS
- 080844844
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 75
- Record Status
- Published
- Publish Date
- 2022-08-30
- Public Version
- 1
- Public Version Date
- 2022-09-07
- Public Version Status
- New
- Public Device Record Key
- cd3ebf1e-f7e5-4f67-adc5-7c4dc03efe14
Device Description
90ML/48MM SPCW/LBL, NTL CAP,ST
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Radiation Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FMH | CONTAINER, SPECIMEN, STERILE | Pathology | 864.3250 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47775 | General specimen container IVD, no additive/medium | An empty covered receptacle containing no additives or media intended to be used for the collection, and preservation and/or transport, of more than one type of clinical specimen (e.g., urine, faeces, sputum, mucous, tissue) derived from different body regions for in vitro diagnostic investigation. It does not contain patient-contact specimen sampling/extraction devices such as swabs/brushes. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30850016060441 | GS1 | Case | 400 | In Commercial Distribution | |
| Primary | 10850016060447 | GS1 | ||||
| Unit of Use | 80850016060446 | GS1 |