FDA UDI
In Commercial Distribution
🇺🇸 United States
Koh Cup
DI: 00888937015751
·
Model: KCS-40
·
Coopersurgical, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Koh Cup
- Primary DI
- 00888937015751
- Version / Model
- KCS-40
- Company Name
- Coopersurgical, Inc.
- Labeler DUNS
- 801895244
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-01
- Public Version
- 3
- Public Version Date
- 2024-02-28
- Public Version Status
- Update
- Public Device Record Key
- 97b4fee3-c066-4ccd-a192-e8beb29c3646
Device Description
Koh Cup 4.0 cm Stainless Steel Vaginal Fornices Delineator
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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HEW | Culdoscope (And Accessories) | Obstetrics/Gynecology | 884.1640 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63992 | Uterine manipulator cervical cup/transilluminator | A sterile distal component of a uterine manipulator designed to fit over the portio vaginalis to: 1) allow manipulation of the uterus under suction whilst preventing laparoscopic insufflation gas from escaping from the cervix (during hysterectomy); and 2) direct light from an independent light source for transillumination of the uterus/cervix (especially the posterior vaginal fornix) from a laparoscopic view point (through the diaphanoscopy effect). It consists of a small plastic cap. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00888937015751 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Inner diameter; 4.0 cm |