FDA UDI
In Commercial Distribution
🇺🇸 United States
Century Uterine Manipulator
DI: GYNX101601
·
Model: 10-160
·
GYNEX CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
12
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Basic Information
- Brand Name
- Century Uterine Manipulator
- Primary DI
- GYNX101601
- Version / Model
- 10-160
- Company Name
- GYNEX CORPORATION
- Labeler DUNS
- 012997685
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 12
- Record Status
- Published
- Publish Date
- 2016-10-10
- Public Version
- 5
- Public Version Date
- 2023-06-29
- Public Version Status
- Update
- Public Device Record Key
- db02edbd-75b3-4b5f-9180-80f6b4f26d8d
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- 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 |
|---|---|---|---|---|
| 58051 | Uterine manipulator, single-use | A sterile, hand-held manual surgical instrument designed to atraumatically mechanically manipulate the position of the uterus during a gynaecological intervention (e.g., laparoscopy) to enable uterine control and improved visibility of the pelvic anatomy, as well as for chromotubation. The device typically consists of a long shaft with an inflatable balloon at the distal end which is transcervically placed inside the uterus and inflated, via a connected syringe (sometimes included), with sterile saline or air; once inflated, the operator can manipulate the uterus. Deflation is a reverse of the inflation process. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | GYNX101601 | HIBCC | ||||
| Unit of Use | GYNX101600 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K022503 | 000 |