FDA UDI
In Commercial Distribution
🇺🇸 United States
20GA Forceps - Non-Sterile
DI: 00632307000072
·
Model: PD420.00
·
PEREGRINE SURGICAL, LTD.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- 20GA Forceps - Non-Sterile
- Primary DI
- 00632307000072
- Version / Model
- PD420.00
- Company Name
- PEREGRINE SURGICAL, LTD.
- Labeler DUNS
- 622467348
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-05-06
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- d8aed457-e9ff-44cf-8cb8-b9a6cc8c5cf8
Device Description
20GA Forceps - Non-Sterile
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
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HNR | FORCEPS, OPHTHALMIC | Ophthalmic | 886.4350 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16209 | Ophthalmic tissue forceps, reusable | A hand-held ophthalmic surgical instrument designed to grasp, manipulate, compress, pull, or join eye and/or surrounding tissues during a surgical intervention. It is typically: 1) a one-piece instrument with a tweezers-like design having two conjoined blades with serrated tips at the working end; or 2) an instrument tip, with grasping blades at the distal end, that is inserted into a dedicated handle through which the blades are operated. It is typically made of high-grade stainless steel and plastic materials, and is available in various sizes. This is a reusable device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10632307000079 | GS1 | Box | 5 | In Commercial Distribution | |
| Primary | 00632307000072 | GS1 |
Customer Contacts
- Phone
- +1(215)348-0456
- [email protected]
- Phone
- +1(215)348-0456
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Needle Gauge | 20 | Gauge | |
| Device Size Text, specify | 20 Gauge Needle |