Identity
- Trade Name
- ALLY Uterine Positioning System® FDA UDI
- Generic Name
- Uterine manipulator, reusable FDA UDI
- Device Name
- ALLY Uterine Positioning System® FDA UDI
- Model / Reference
- AU-UPS FDA UDI
- Description
- ALLY Uterine Positioning System® FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00888937015836 FDA UDI
- 510(k) Number
- K141523 FDA UDI
- FDA Product Code
- LKF FDA UDI
- GMDN Term
- Uterine manipulator, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.4530 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Uterine manipulator, reusable
ALLY Uterine Positioning System® by CooperSurgical, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Uterine manipulator, reusable.
- Surgical Direct — SURGICAL DIRECT, INC. · Class II
- Ambler Surgical — Ambler Surgical, LLC · Class I
- Surgical Direct — SURGICAL DIRECT, INC. · Class II
- Ambler Surgical — Ambler Surgical, LLC · Class I
- Ambler Surgical — Ambler Surgical, LLC · Class I
- RZ Medizintechnik GmbH — RZ-Medizintechnik GmbH · Class I
- RZ Medizintechnik GmbH — RZ-Medizintechnik GmbH · Class I
- Surgical Direct — SURGICAL DIRECT, INC. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
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
- CooperSurgical, Inc.
Sources (2)
- FDA UDI 9e153771-3027-42ac-b33d-f3d4747036df 34 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 4, 2026