FDA UDI
In Commercial Distribution
🇺🇸 United States
Sontec Forceps Holder
DI: 00192896107632
·
Model: 125-668
·
SONTEC INSTRUMENTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Sontec Forceps Holder
- Primary DI
- 00192896107632
- Version / Model
- 125-668
- Company Name
- SONTEC INSTRUMENTS, INC.
- Labeler DUNS
- 040729840
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-04-15
- Public Version
- 2
- Public Version Date
- 2023-05-03
- Public Version Status
- Update
- Public Device Record Key
- 63f8bf01-8bee-4a98-bc63-cbc094d2401f
Device Description
Sontec Forceps Holder With Center Lock 2.50 X 10.0 Inches
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
- 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
- ["Dry Heat Sterilization", "Moist Heat or Steam Sterilization"]
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MDM | INSTRUMENT, MANUAL, SURGICAL, GENERAL USE | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62851 | Surgical instrument interim-placement holder, reusable | A device intended to be used in the operating room (OR) by staff to safely hold a manual, surgical instrument(s) [e.g., needle, scalpel, scissors] when not in use during surgery, to avoid damage to the instrument, and/or for temporary storage (e.g., to enable easy transfer/handling of the instrument at reduced risk of injury). It is available in various forms (e.g., rack, puncture cushion, telescopic tube, magnetic mat), and may be attached to a surgical drape; it is not a numbered tray and is not intended for counting of sharps. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00192896107632 | GS1 |
Customer Contacts
- Phone
- +1(800)821-7496
- [email protected]