FDA UDI
In Commercial Distribution
🇺🇸 United States
Gomco Type Circumcision Clamp
DI: 00869401000268
·
Model: 903-018
·
FINE SURGICAL INSTRUMENTS INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Gomco Type Circumcision Clamp
- Primary DI
- 00869401000268
- Version / Model
- 903-018
- Catalog Number
- 903-018
- Company Name
- FINE SURGICAL INSTRUMENTS INC.
- Labeler DUNS
- 103669727
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-10
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 7d9c0a7c-a26b-4572-ba9a-4e7a4d84827e
Device Description
Gomco Type Circumcision Clamp Stainless Steel (German) Infant 1.45cm
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- Yes
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| HXD | CLAMP | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 10869 | Circumcision clamp, reusable | A hand-held manual surgical instrument designed for the controlled removal of the foreskin of the penis during circumcision. It is typically made of high-grade stainless steel and can have various designs, e.g., the Bell clamp. The foreskin is pushed over the bell-shaped protection rod and the glans placed into it. A screw mechanism is tightened so that the foreskin is annular compressed and is cut-off using, e.g., a scalpel, following the compression ring. This is a reusable device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00869401000268 | GS1 |
Customer Contacts
- Phone
- +1(516)292-7400 ext. 12
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Gomco Type CC S/less (German) Infant 1.45cm |