CUVIS-spine Drape
FDA UDIEUDAMEDClass II (US FDA UDI)
by CUREXO, Inc.
Identity
- Trade Name
- Drape EUDAMEDCUVIS-spine Drape FDA UDI
- Generic Name
- Medical equipment/instrument drape, single-use FDA UDI
- Device Name
- Sterilized kit for CUVIS-joint / Drape EUDAMED
- Model / Reference
- CUVIS-joint Drape EUDAMEDBA-30140-000 EUDAMEDRobotic Arm Drape FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800043850356 EUDAMED08800043860768 FDA UDI
- Basic UDI-DI
- 88000438CJEV2 EUDAMED
- FDA Product Code
- PUI FDA UDI
- EMDN Code
- T020199 SURGICAL DRAPES - OTHER EUDAMED
- GMDN Term
- Medical equipment/instrument drape, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4370 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
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
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
Yes
Manufacturing Date
No
Category: Medical equipment/instrument drape, single-use
CUVIS-spine Drape by CUREXO, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Medical equipment/instrument drape, single-use.
- Plasdent — PLASDENT CORP. · Class II
- Exact Medical Manufacturing, Inc. — Exact Medical Manufacturing · Class II
- Proteger — DAS Medical International SRL · Class II
- Machine Bag — Dynarex Corp. · Class I
- TIDIShield — TIDI PRODUCTS, LLC · Class II
- MICROTEK — Microtek Medical LLC · Class II
- Plasdent — PLASDENT CORP. · Class II
- Probe Cover — Advance Medical Designs, Inc. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- CUREXO, Inc.
Sources (2)
- FDA UDI df15b65f-7506-4e0d-92c4-7956f29988e0 34 fields · synced Jul 11, 2026
- EUDAMED 33b1d354-29e4-4d8b-b26c-c217887d0a46 61 fields · synced Jul 11, 2026