FDA Registration
Active
🇺🇸 United States
Peregrine Surgical, LLC.
Reg #: 2529392
·
FEI: 1000121498
·
Expires 2026
Products
11
Proprietary Names
47
Establishment Types
3
Classifications
11
Registration Details
- Registration Name
- Peregrine Surgical, LLC.
- Registration Number
- 2529392
- FEI Number
- 1000121498
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 51 Britain Drive
- City
- New Britain
- State
- PA
- ZIP
- 18901
- Country
- US
Regulatory Submissions
- 510(k) Number
- K233653
Owner / Operator
- Firm Name
- PEREGRINE SURGICAL LLC
- Operator Number
- 9002261
- Address
- 51 BRITAIN DR., --
- City
- New Britain
- State
- PA
- Postal Code
- 18901
- Country
- US
- Correspondent
- Ryan - O'Leary
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Endoilluminator | MPA | Class 2 | Gastroenterology, Urology | No | 2024-09-04 |
| Photocoagulator And Accessories | HQB | Class 2 | Ophthalmic | No | 2013-11-20 |
| Powered Laser Surgical Instrument | GEX | Class 2 | General, Plastic Surgery | No | 2019-10-28 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2012-11-18 |
| Laser, Ophthalmic | HQF | Class 2 | Ophthalmic | No | 2007-11-18 |
| Device, Irrigation, Ocular Surgery | KYG | Class 1 | Ophthalmic | No | 2018-02-28 |
| Forceps, Ophthalmic | HNR | Class 1 | Ophthalmic | No | 2010-08-02 |
| Instrument, Vitreous Aspiration And Cutting, Ac-Powered | HQE | Class 2 | Ophthalmic | No | 2008-11-12 |
| Cannula, Ophthalmic | HMX | Class 1 | Ophthalmic | No | 2004-06-21 |
| Ring, Ophthalmic (Flieringa) | HNH | Class 1 | Ophthalmic | No | 2008-01-19 |
| Unit, Phacofragmentation | HQC | Class 2 | Ophthalmic | No | 2023-10-31 |
Proprietary Names
Midfield Endoillumination Probe
3269.M04-00,3269.M05-00,3269.M06-00
Peregrine 23ga and 25ga Adjustable Chandelier Illuminator
BL5234,BL5235
Chandeliers
G-Probe
Exempt
PD720.10,PD720.11,PD720.12,PD720.13,PD723.10,PD723.11,PD723.12,PD723.13,PD725.10,PD725.11,PD725.12,PD725.13,BL5290,BL5293,BL5295
Standard (Non-Illuminating) Laser Probes
GA-0040025,GA-0040051,GA-0040022,GA-0040046,GA-0040021,GA-0040047,GA-0040012,GA-0040038,GA-0040009,GA-0040035,GA-0040008,GA-0040034
OtoProbe
Infusion Sleeve
DMEK/DSAEK Infusion Sleeve
EndoProbe
G-Probe Illuminate
Illuminated Laser Probes
BL5295L,BL5295LC,GA-0040003,GA-0040004,GA-0040005,GA-0040006,GA-0040010,GA-0040011,GA-0040087,GA-0040089,GA-0040073
PD723.37,PD723.38,PD725.30,PD725.31,PD725.32,PD725.33,PD725.35,PD725.36,PD725.37,PD725.38,BL5290L,BL5290LC,BL5293L,BL5293LC
GA-0040075,GA-0040079,GA-0040016,GA-0040017,GA-0040018,GA-0040019,GA-0040023,GA-0040024,GA-0040099,GA-0040101
GA-0040103,GA-0040105,GA-0040113,GA-0040115
PD720.30,PD720.31,PD720.32,PD720.33,PD720.35,PD720.36,PD720.37,PD720.38,PD723.30,PD723.31,PD723.32,PD723.33,PD723.35,PD723.36
DMEK Forceps
DMEK/DSAEK Forceps
MicroPulse P3 Device
GA-0040023,GA-0040024,GA-0040099,GA-0040101,GA-0040103,GA-0040105,GA-0040113,GA-0040115
GA-0040005,GA-0040006,GA-0040010,GA-0040011,GA-0040087,GA-0040089,GA-0040073,GA-0040075,GA-0040079,GA-0040016,GA-0040017,GA-0040018,GA-0040019
PD725.30,PD725.31,PD725.32,PD725.33,PD725.35,PD725.36,PD725.37,PD725.38,BL5290L,BL5290LC,BL5293L,BL5293LC,BL5295L,BL5295LC,GA-0040003,GA-0040004
PD720.30,PD720.31,PD720.32,PD720.33,PD720.35,PD720.36,PD720.37,PD720.38,PD723.30,PD723.31,PD723.32,PD723.33,PD723.35,PD723.36,PD723.37,PD723.38
PD100.13, PD123.13
Light Pipes - Peregrine
PD720.60/PD720.60HT*,PD720.62/PD720.62HT*,PD723.60/PD723.60HT*,PD723.62/PD723.62HT*,BL5290ASP,BL5290ASPH
BL5293ASP,BLS5293ASPH,GA-0040013,GA-0040039,GA-0040000,GA-0040026
Aspirating Laser Probes
PD1030,PD103.12,PD103.23,PD1040,PD104.23,PD1233A,PD125.25,PD126.25,PD127.25,PD128.25
PD1000,PD1001,PD1002,PD1003,PD1004,PD1006,PD1007,PD100.12,PD100.23,PD1010,PD1011,PD1012,PD1013,PD1014
PD1016,PD101.11,PD101.23,PD1020,PD1021,PD1022,PD1023,PD1024,PD1026,PD1027,PD102.11,PD102.12,PD102.23
Acculite Endo Probe - EndoOcular Illuminating Probe
PD100.14,PD100.14B,PD101.14,PD102.14,PD103.14,PD104.14,PD123.14,PD123.14B,PD125.14,PD125.14B
Laser, ophthalmic-Acculite Endo Ocular
BL5820 20GA Wide Angle Light Pipe
BL5723 23GA Light Pipe
BL5825 25GA Wide angle Light Pipe
BL5823 23GA Wide Angle Light Pipe
BL5725 25GA Light Pipe
Laser, ophthalmic - Acculite Endo Oto
PD725.37SA,,GA-0040005,GA-0040006,GA-0040079,GA-0040018,GA-0040019,GA-0040103,GA-0040105
Illuminating Laser Probes - Peregrine
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Repack or Relabel Medical Device