FDA UDI
In Commercial Distribution
🇺🇸 United States
ALLY Uterine Positioning System®
DI: 00888937015836
·
Model: AU-UPS
·
Coopersurgical, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ALLY Uterine Positioning System®
- Primary DI
- 00888937015836
- Version / Model
- AU-UPS
- Company Name
- Coopersurgical, Inc.
- Labeler DUNS
- 801895244
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-02-10
- Public Version
- 7
- Public Version Date
- 2024-02-28
- Public Version Status
- Update
- Public Device Record Key
- 9e153771-3027-42ac-b33d-f3d4747036df
Device Description
ALLY Uterine Positioning System®
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LKF | Cannula, Manipulator/Injector, Uterine | Obstetrics/Gynecology | 884.4530 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63994 | Uterine manipulator, reusable | A hand-held, manually-operated, surgical instrument designed to mechanically manipulate the position of the uterus during a gynaecological intervention (e.g., laparoscopic hysterectomy), to enable uterine control and improved visibility of the pelvic anatomy. The device typically consists of a probe which is positioned within an introduction sheath/handpiece and includes an illuminator for transillumination of the uterus/cervix during laparoscopy (through the diaphanoscopy effect); it typically includes a suction line (for aspiration and/or tissue retention/manipulation). This is a reusable device intended to be sterilized prior to use. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00888937015836 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K141523 | 000 |