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T-Handle Light Sleeves
EUDAMEDFDA UDIClass I (EU MDR)
Ref BCLSTModel Barrier Covers
Identity
- Trade Name
- T-Handle Light Sleeves EUDAMEDFDA UDI
- Generic Name
- Medical equipment/instrument drape, single-use FDA UDI
- Device Name
- Light Sleeves, 4 in x 5.75 in / 10.2 cm x 14.6 cm (Clear with white arrow) FDA UDI
- Model / Reference
- Barrier Covers EUDAMEDBCLST EUDAMEDFDA UDI
- Description
- Light Sleeves, 4 in x 5.75 in / 10.2 cm x 14.6 cm (Clear with white arrow) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10732224003310 EUDAMEDFDA UDI
- Basic UDI-DI
- 0732224Cover63 EUDAMED
- Unit of Use DI
- 00732224003313 EUDAMED
- FDA Product Code
- NRU FDA UDI
- EMDN Code
- T030199 COVERS, INSTRUMENTS AND EQUIPMENT - OTHER EUDAMED
- GMDN Term
- Medical equipment/instrument drape, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.6250 FDA UDI
- Market of Registration
- Germany 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
T-Handle Light Sleeves by Crosstex International, Inc. — 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 | 0732224Cover63 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Crosstex International Inc
- EUDAMED SRN
- US-MF-000009642
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED fc7f74ec-4734-4e44-a712-ea1217252216 61 fields · synced Jun 18, 2026
- FDA UDI 88b17e19-2768-427a-9302-d9747ce360f0 34 fields · synced May 30, 2026