FDA UDI
In Commercial Distribution
🇺🇸 United States
V.A.T.S. BULLDOG APPLYING FORCEPS
DI: 00192896003729
·
Model: 2100-829
·
SONTEC INSTRUMENTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- V.A.T.S. BULLDOG APPLYING FORCEPS
- Primary DI
- 00192896003729
- Version / Model
- 2100-829
- Company Name
- SONTEC INSTRUMENTS, INC.
- Labeler DUNS
- 040729840
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-08-29
- Public Version
- 1
- Public Version Date
- 2018-10-01
- Public Version Status
- New
- Public Device Record Key
- fbf7ea82-fcc9-4d47-b67a-041b75b31ea5
Device Description
V.A.T.S. BULLDOG APPLYING FORCEPS WITH RATCHET ANGLED
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 |
|---|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 42468 | Clamp manipulation forceps | A hand-held manual surgical instrument with a dedicated, slotted, working end that is designed to accept, grasp, open, apply and remove small types of bulldog/vascular clamps. It is typically made of high-grade stainless steel with jaws at the working end designed to accept the clamp; this gives the surgeon greater range of use of the bulldog clamp into the wound. It has typically a straight design with a slightly curved geometry toward the working end. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Previous | B09921008290 | HIBCC | ||||
| Primary | 00192896003729 | GS1 |
Customer Contacts
- Phone
- 800-821-7496
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K152400 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 60° Jaw | ||
| Length | 13 | Inch |