FDA UDI
In Commercial Distribution
🇺🇸 United States
FREEMAN SKIN HOOK
DI: 00192896042483
·
Model: 475-546
·
SONTEC INSTRUMENTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- FREEMAN SKIN HOOK
- Primary DI
- 00192896042483
- Version / Model
- 475-546
- Catalog Number
- 475-546
- Company Name
- SONTEC INSTRUMENTS, INC.
- Labeler DUNS
- 040729840
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-09-14
- Public Version
- 1
- Public Version Date
- 2018-10-15
- Public Version Status
- New
- Public Device Record Key
- 18510990-c660-4280-b8b8-7257908aa631
Device Description
FREEMAN SKIN HOOK WITH FINGER LOOP
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", "Dry Heat Sterilization"]
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GDG | HOOK, SURGICAL, GENERAL & PLASTIC SURGERY | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35110 | Skin/tissue hook | A hand-held manual surgical instrument designed to hook skin or tissue in order to grasp, apply traction, and lift the skin/tissue during a surgical intervention. It is typically a shaft-like instrument with small double hooks at the distal end and a handle at the proximal end. The hooks are curved in opposite directions and when the device is placed onto the skin or tissue to be grasped, it is twisted clockwise so that the hooks lock into the skin/tissue. Also known as a tissue pick, it is not unlike a hooked wound retractor. It is made of high-grade stainless steel and may be supplied with a cylindrical steel protecting sheath for storage and sterilization. This is a reusable device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00192896042483 | GS1 |
Customer Contacts
- Phone
- +1(800) 821-7496
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 4 | Inch |