Identity
- Trade Name
- Halyard EUDAMEDFDA UDI
- Generic Name
- Patient surgical drape, single-use, non-sterile FDA UDI
- Device Name
- Surgical Drapes Non Sterile EUDAMEDEENT Split Drape 76 in. x 124 in. / 193 cm x 314 cm FDA UDI
- Model / Reference
- 79351 EUDAMEDFDA UDI
- Description
- EENT Split Drape 76 in. x 124 in. / 193 cm x 314 cm FDA UDI
Identifiers
- Catalog Number
- 79351 FDA UDI
- Primary DI / UDI-DI
- 30680651793516 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 e877362d-7cba-4a1c-b4f5-8cb95571351c 35 fields · synced Oct 8, 2026
- EUDAMED 48520daf-81ac-48c7-b1c1-384dd5ba7e76 61 fields · synced Oct 8, 2026