FDA UDI
Not in Commercial Distribution
🇺🇸 United States
DMEK Forceps
DI: 00632307002236
·
Model: PD427.00
·
PEREGRINE SURGICAL, LTD.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- DMEK Forceps
- Primary DI
- 00632307002236
- Version / Model
- PD427.00
- Company Name
- PEREGRINE SURGICAL, LTD.
- Labeler DUNS
- 622467348
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-05-15
- Public Version
- 3
- Public Version Date
- 2020-08-17
- Public Version Status
- Update
- Public Device Record Key
- 2f777985-8878-493b-9afb-d336f85bfb4e
- Distribution End Date
- 2020-08-14
Device Description
DMEK Forceps
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
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- ["Ethylene Oxide", "Moist Heat or Steam Sterilization"]
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HNR | Forceps, Ophthalmic | Ophthalmic | 886.4350 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62469 | Ophthalmic soft-tissue manipulation forceps, probe-like, reusable | A hand-held manual instrument designed to grasp and manipulate intraocular tissues during ophthalmic surgery (e.g., anterior segment surgery, vitreo-retinal procedures, iridectomy, capsulorhexis). It has a probe-like design with a proximal handle (typically cylindrical), a thin cannula-like shaft, and small grasping blades that protrude from the distal end of the shaft. This is a reusable device intended to be sterilized prior to use. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00632307002236 | GS1 |
Customer Contacts
- Phone
- 215-348-0456
- [email protected]
- Phone
- 215-348-0456
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Needle Gauge | 27 | Gauge |