Identity
- Trade Name
- Vitrectomy Infusion Sleeve FDA UDI
- Generic Name
- Ophthalmic tissue forceps, reusable FDA UDI
- Device Name
- Vitrectomy Infusion Sleeve FDA UDI
- Model / Reference
- PD505.06 FDA UDI
- Description
- Vitrectomy Infusion Sleeve FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00632307001567 FDA UDI
- FDA Product Code
- HMX FDA UDI
- GMDN Term
- Ophthalmic tissue forceps, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.4350 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Ethylene Oxide FDA UDI
Dimensions & Sizes
- Size
- Needle Gauge — 20 Gauge FDA UDI
Category: Ophthalmic tissue forceps, reusable
Vitrectomy Infusion Sleeve by Peregrine Surgical, LLC. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ophthalmic tissue forceps, reusable.
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- 20GA Forceps - Sterile — Peregrine Surgical, LLC. · Class I
- 20GA Forceps - Non-Sterile — Peregrine Surgical, LLC. · Class I
- 23GA Forceps - Non-Sterile — Peregrine Surgical, LLC. · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Peregrine Surgical, LLC.
Sources (1)
- FDA UDI 2583dd13-f18d-46af-b1bb-04cfaa69af5d 35 fields · synced May 31, 2026