Identity
- Trade Name
- ALLY UPS® EUDAMEDAdapter Drape (For RUMI II or Advincula Arch) FDA UDI
- Generic Name
- Medical equipment/instrument drape, single-use FDA UDI
- Device Name
- Adapter Drape EUDAMEDAdapter Drape (For RUMI II or Advincula Arch) FDA UDI
- Model / Reference
- AU-AD EUDAMEDFDA UDIAUD-AD EUDAMED
- Description
- Adapter Drape (For RUMI II or Advincula Arch) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00888937015812 EUDAMEDFDA UDI
- Basic UDI-DI
- 0888937TD052ZN EUDAMED
- 510(k) Number
- K141523 FDA UDI
- FDA Product Code
- LKF FDA UDI
- EMDN Code
- T020102 SPECIALISTIC SURGERY DRAPES EUDAMED
- GMDN Term
- Medical equipment/instrument drape, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 884.4530 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Ally Ups® by CooperSurgical, 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 | 0888937TD052ZN | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- CooperSurgical, Inc.
- EUDAMED SRN
- US-MF-000002607
- Authorised Representative
- CooperSurgical Distribution B.V. NL-AR-000000059
Sources (2)
- EUDAMED d5bd3131-4b7e-4168-9c0a-0c36ed86a329 61 fields · synced Jun 9, 2026
- FDA UDI 41b9aa77-3676-4a55-986b-bf1c70f97c32 34 fields · synced May 30, 2026