FDA UDI
In Commercial Distribution
🇺🇸 United States
Novo Surgical
DI: G586G6153560
·
Model: G6153-56
·
NOVO SURGICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Novo Surgical
- Primary DI
- G586G6153560
- Version / Model
- G6153-56
- Catalog Number
- G6153-56
- Company Name
- NOVO SURGICAL, INC.
- Labeler DUNS
- 033029433
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-12-18
- Public Version
- 1
- Public Version Date
- 2023-12-26
- Public Version Status
- New
- Public Device Record Key
- 91c98d73-0f55-4e11-9e1f-b4b6d286aa8c
Device Description
demartel-wolfson clamp holder, 9" (22.9 cm)
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
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- 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 |
|---|---|---|---|---|
| GEN | FORCEPS, GENERAL & PLASTIC SURGERY | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64147 | Surgical gastrointestinal clamp | A manual, clip-like, surgical device designed specifically to clamp tissues of the gastrointestinal tract (e.g., colon) during open surgery; it does not have handles (i.e., not forceps-like) and is not intended for general manipulation/dissection of tissues. It may be referred to as a Demartel-Wolfson Clamp and is designed with blades hinged at one end and with a locking bar at the other. 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 | G586G6153560 | HIBCC |
Customer Contacts
- Phone
- +1(877)860-6686
- [email protected]