Identity
- Trade Name
- ALLY II UPS FDA UDI
- Generic Name
- Uterine manipulator, reusable FDA UDI
- Device Name
- ALLY II UPS (Uterine Positioning System) FDA UDI
- Model / Reference
- LAU-UPS2 FDA UDI
- Description
- ALLY II UPS (Uterine Positioning System) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00888937027587 FDA UDI
- 510(k) Number
- K223064 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
Yes
FDA UDI
Category: Uterine manipulator, reusable
Ally Ii Ups by CooperSurgical, Inc. — Class II — FDA UDI — listed in FDA GUDID — 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
Cleared under the same submission
K223064 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- CooperSurgical, Inc.
Sources (1)
- FDA UDI c4f663a0-06d6-4d9d-848b-94d8e46500d1 34 fields · synced Jun 9, 2026