Identity
- Trade Name
- Pergo EUDAMEDFDA UDI
- Generic Name
- Postsurgical eye shield, hermetic FDA UDI
- Device Name
- Eye Safety Tape EUDAMEDEye Safety Tape Adult Sensitive FDA UDI
- Model / Reference
- 05TD0019 EUDAMEDFDA UDI
- Description
- Eye Safety Tape Adult Sensitive FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08681756010356 EUDAMEDFDA UDI
- Basic UDI-DI
- 8682952415563CX EUDAMED
- FDA Product Code
- HMP FDA UDI
- EMDN Code
- M040301 EYE PADS, COTTON OR NON-WOVEN MATERIALS EUDAMED
- GMDN Term
- Postsurgical eye shield, hermetic FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4440 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Pergo by Pergo Medikal Ve Ilac Sanayi Anonim Sirketi — Class I — FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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
- Pergo Medikal Ve Ilac Sanayi Anonim Sirketi
Sources (2)
- FDA UDI f5b989a5-a69a-4d6a-b821-d3dc61d99428 33 fields · synced Oct 8, 2026
- EUDAMED bd637c0f-7e67-4657-810d-ae0db434b475 61 fields · synced Jul 11, 2026