Cable Sleeve
by CIVCO Medical Instruments Co., Inc. dba CIVCO and CIVCO Medical Solutions EUDAMEDGUDID
Active
Ref IVL10CS, IVL1CS
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing GUDID | Number10841436127056 | Date27 Jul 2026 | StatusIn distribution |
| European Union | CE/MDR EUDAMED | Number0841436101TD202A2NR | Date28 May 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
- European Union
- United States
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Recalls
No FDA recalls on record, checked 23 Oct 2026.
Specification
- Generic Name
- Medical equipment/instrument drape, single-use
- Device Name
- Equipment Drapes (Connector cover)
- Model / Ref / Catalog
- IVL10CS, IVL1CS
- Primary DI / UDI-DI
- 10841436127056
- Basic UDI-DI
- 0841436101TD202A2NR
- 510(k) Number
- FDA Product Code
- ITX
- EMDN Code
- T030199 Covers, instruments and equipment - other
- GMDN Term
- Medical equipment/instrument drape, single-use
- Device Class
- Class I EUDAMEDClass II GUDID
- Regulation Number
- 892.1570
- Market of Registration
- Germany
- Commercial Distribution
- In Commercial Distribution
- Sterilization Method
- Ethylene Oxide
- Size
- Length — 250 CentimeterWidth — 12.7 Centimeter
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device Class | Class I | Class II |
Manufacturer details
- EUDAMED SRN
- US-MF-000008229
- Authorised representative
- MPS Medical Product Service GmbH DE-AR-000005009
Other devices from CIVCO Medical Instruments Co., Inc. dba CIVCO and CIVCO Medical Solutions
See all devices from CIVCO Medical Instruments Co., Inc. dba CIVCO and CIVCO Medical Solutions →
Properties
Other properties (17)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
- Over-the-Counter: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No