FDA UDI
In Commercial Distribution
🇺🇸 United States
HUMI
DI: 00888937013238
·
Model: 6001
·
Coopersurgical, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- HUMI
- Primary DI
- 00888937013238
- Version / Model
- 6001
- Company Name
- Coopersurgical, Inc.
- Labeler DUNS
- 801895244
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-14
- Public Version
- 6
- Public Version Date
- 2024-02-28
- Public Version Status
- Update
- Public Device Record Key
- d05eadf7-ef43-442f-81ed-49cb6d345b4c
Device Description
HUMI® Harris-Kronner Uterine Manipulator-Injector O.D.: 5 mm • Length: 33 cm (13") • Recommended Balloon Inflation: Air 10 cc
Device Characteristics
- Single Use
- Yes
- 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
- 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 |
|---|---|---|---|---|
| KNA | Instrument, Manual, Specialized Obstetric-Gynecologic | 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 |
|---|---|---|---|---|---|---|
| Package | 20888937013232 | GS1 | 12 | In Commercial Distribution | ||
| Primary | 00888937013238 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K770727 | 000 |