FDA UDI
Not in Commercial Distribution
🇺🇸 United States
TENACULUM GRASPING FORCEP INSERT
DI: B09929012410
·
Model: 2901-241
·
SONTEC INSTRUMENTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- TENACULUM GRASPING FORCEP INSERT
- Primary DI
- B09929012410
- Version / Model
- 2901-241
- Company Name
- SONTEC INSTRUMENTS, INC.
- Labeler DUNS
- 040729840
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-19
- Public Version
- 8
- Public Version Date
- 2019-08-21
- Public Version Status
- Update
- Public Device Record Key
- ffd6aedd-760e-4a12-bab9-99f08dd894da
- Distribution End Date
- 2018-06-22
Device Description
TENACULUM GRASPING FORCEPS DOUBLE-ACTION JAWS FOR TUBE SHAFT
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
- No
- 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 |
|---|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | 878.4400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35080 | Rigid endoscopic tissue manipulation forceps, reusable | A rigid, hand-held manual surgical instrument designed to be introduced through the working channel of an endoscope and/or an endoscopic port (e.g., laparoscopic port) primarily for grasping and manipulating tissues during endoscopic surgery. It has proximal controls (e.g., scissors-like handles), a rigid long slender shaft, and distal grasping jaws; it is not an electrosurgical device and is not dedicated to biopsy. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B09929012410 | HIBCC |
Customer Contacts
- Phone
- 800-821-7496
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K002877 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 360 | Millimeter | |
| Device Size Text, specify | 5mm Shaft |