FDA UDI
In Commercial Distribution
🇺🇸 United States
ARTHROSCOPIC GRASPING FORCEPS
DI: 00192896084162
·
Model: 1271-614
·
SONTEC INSTRUMENTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ARTHROSCOPIC GRASPING FORCEPS
- Primary DI
- 00192896084162
- Version / Model
- 1271-614
- Catalog Number
- 1271-614
- Company Name
- SONTEC INSTRUMENTS, INC.
- Labeler DUNS
- 040729840
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-09-21
- Public Version
- 1
- Public Version Date
- 2018-10-22
- Public Version Status
- New
- Public Device Record Key
- 2f118675-2b29-49a0-83dd-0db2e756bc05
Device Description
ARTHROSCOPIC GRASPING FORCEPS WITH OVERLOAD CONE RIGHT ANGLED TIP
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
- ["Dry Heat Sterilization", "Moist Heat or Steam Sterilization"]
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HTD | FORCEPS | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35732 | Rigid endoscopic biopsy forceps, reusable | A rigid, manual, non-electrosurgical instrument intended to obtain tissue specimens during endoscopic procedures (e.g., laparoscopy, thoracoscopy, spinoscopy, arthroscopy). It is typically constructed as a long instrument with one sliding and one stationary rod whose distal ends are equipped with scissors-like cups with cutting edge rims, which are operated by a control handle at the proximal end of the instrument. It is introduced into the body through an artificial orifice of the body or the working channel of the endoscope. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00192896084162 | GS1 |
Customer Contacts
- Phone
- +1(800) 821-7496
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 1 x 2 Teeth | ||
| Device Size Text, specify | 45 Degree Tip | ||
| Device Size Text, specify | 3.4 Millimeter Tip | ||
| Length | 6 | Inch |