Identity
- Trade Name
- Pergo FDA UDI
- Generic Name
- Postsurgical eye shield, hermetic FDA UDI
- Device Name
- Eye Safety Tape Adult FDA UDI
- Model / Reference
- 05TD0012 FDA UDI
- Description
- Eye Safety Tape Adult FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08681756010028 FDA UDI
- FDA Product Code
- HMP FDA UDI
- GMDN Term
- Postsurgical eye shield, hermetic FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4440 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Category: Postsurgical eye shield, hermetic
Pergo by Pergo Medikal Ve Ilac Sanayi Anonim Sirketi — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Postsurgical eye shield, hermetic.
- Bausch + Lomb — Bausch & Lomb Incorporated · Class I
- Pergo — PERGO MEDIKAL VE ILAC SANAYI ANONIM SIRKETI · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Pergo Medikal Ve Ilac Sanayi Anonim Sirketi
Sources (1)
- FDA UDI 42f8beb3-6ace-4b44-9bf1-fe6410250a01 33 fields · synced May 30, 2026