Identity
- Trade Name
- Halyard EUDAMEDFDA UDI
- Generic Name
- Patient surgical drape, single-use, non-sterile FDA UDI
- Device Name
- Surgical Drapes Non Sterile EUDAMEDLaparoscopy/Pelviscopy Drape 100 in. x 110 in. / 254 cm x 279 cm FDA UDI
- Model / Reference
- 76377 EUDAMEDFDA UDI
- Description
- Laparoscopy/Pelviscopy Drape 100 in. x 110 in. / 254 cm x 279 cm FDA UDI
Identifiers
- Catalog Number
- 76377 FDA UDI
- Primary DI / UDI-DI
- 30680651763779 EUDAMEDFDA UDI
- Basic UDI-DI
- 06806517SD001CC EUDAMED
- FDA Product Code
- PUI FDA UDI
- EMDN Code
- T020102 SPECIALISTIC SURGERY DRAPES EUDAMED
- GMDN Term
- Patient surgical drape, single-use, non-sterile FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4370 FDA UDI
- Market of Registration
- Belgium 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Patient surgical drape, single-use, non-sterile
Halyard by O&M Halyard, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- O&M Halyard, Inc.
Sources (2)
- FDA UDI 8c71f7e3-b4fd-472c-bc5c-7ee9e7f5baf1 35 fields · synced Oct 8, 2026
- EUDAMED 25e9cebd-5c15-421c-9497-312c8eaa8ba6 61 fields · synced Oct 8, 2026