Identity
- Trade Name
- CS 7600 Hygienic Sheath EUDAMEDFDA UDI
- Generic Name
- Medical equipment/instrument drape, single-use FDA UDI
- Device Name
- CS 7600 HYG SHEATHS SIZE 0 EUDAMEDCS 7600 HYG SHEATHS SIZE 2 200 PCS FDA UDI
- Model / Reference
- 5942636 EUDAMEDCS 7600 Hygienic Sheath FDA UDI
- Description
- CS 7600 HYG SHEATHS SIZE 2 200 PCS FDA UDI
Identifiers
- Catalog Number
- 5942636 FDA UDI
- Primary DI / UDI-DI
- 40192155942637 EUDAMEDFDA UDI
- Basic UDI-DI
- 01921557600HSW8 EUDAMED
- FDA Product Code
- KQM FDA UDI
- EMDN Code
- T030102 COVER SHEATHS, INSTRUMENTS AND EQUIPMENTS EUDAMED
- GMDN Term
- Medical equipment/instrument drape, single-use 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
Yes
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
CS 7600 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 | 01921557600HSW8 | Class I | Active |
| 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
- Carestream Dental LLC
- EUDAMED SRN
- US-MF-000003727
- Authorised Representative
- TROPHY FR-AR-000001797
Sources (2)
- EUDAMED aa0bac26-f113-43aa-a3d7-200e3c62be5e 61 fields · synced Jul 9, 2026
- FDA UDI 2d4564fa-df43-41a9-93bf-55469238849b 34 fields · synced May 30, 2026