Identity
- Trade Name
- Hygienic Sheath EUDAMEDFDA UDI
- Generic Name
- Medical equipment drape, single-use, non-sterile FDA UDI
- Device Name
- HYGIENIC SHEATHS #0 EUDAMEDHYGIENIC SHEATHS #2 - 200 PCS FDA UDI
- Model / Reference
- 5942578 EUDAMEDHygienic Sheath FDA UDI
- Description
- HYGIENIC SHEATHS #2 - 200 PCS FDA UDI
Identifiers
- Catalog Number
- 5942578 FDA UDI
- Primary DI / UDI-DI
- 40192155942576 EUDAMEDFDA UDI
- Basic UDI-DI
- 0192155HYGIENICSHEATHJ6 EUDAMED
- FDA Product Code
- KQM FDA UDI
- EMDN Code
- T030102 COVER SHEATHS, INSTRUMENTS AND EQUIPMENTS EUDAMED
- GMDN Term
- Medical equipment drape, single-use, non-sterile FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4160 FDA UDI
- Market of Registration
- France 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
Hygienic Sheath by Carestream Dental LLC — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0192155HYGIENICSHEATHJ6 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Carestream Dental LLC
- EUDAMED SRN
- US-MF-000003727
- Authorised Representative
- TROPHY FR-AR-000001797
Sources (2)
- EUDAMED 0a124722-4707-45f2-8c93-7a6a4e866240 61 fields · synced Jun 18, 2026
- FDA UDI a110380c-7fde-4383-801a-5bfe27952bc7 34 fields · synced May 29, 2026