FDA UDI
In Commercial Distribution
🇺🇸 United States
MICASEPT BIOPSY AND GRASPING FORCEPS
DI: 00192896008519
·
Model: 20920-06
·
SONTEC INSTRUMENTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- MICASEPT BIOPSY AND GRASPING FORCEPS
- Primary DI
- 00192896008519
- Version / Model
- 20920-06
- Company Name
- SONTEC INSTRUMENTS, INC.
- Labeler DUNS
- 040729840
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-08-23
- Public Version
- 2
- Public Version Date
- 2019-07-12
- Public Version Status
- Update
- Public Device Record Key
- 258cbe75-9c61-4964-b43b-9900efecc948
Device Description
MICASEPT BIOPSY AND GRASPING FORCEPS WITH 2 FANGS WITH ROUND RATCHET
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
- ["Dry Heat Sterilization", "Moist Heat or Steam 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 |
|---|---|---|---|---|
| 11775 | Open-surgery biopsy forceps, reusable | A hand-held manual surgical instrument designed to obtain soft-tissue biopsy specimens from an open surgical wound or from within/near a large natural orifice (e.g., vagina, rectum) for histopathological examination; it is not intended for endoscopic or catheterized access. It is a metallic forceps-like instrument with a distal mechanism designed to bite/punch the biopsy sample and hold it for extraction when the handles are squeezed together. It is not designed for cutting bone (i.e., not a rongeur). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Previous | B09920920060 | HIBCC | ||||
| Primary | 00192896008519 | GS1 |
Customer Contacts
- Phone
- 8008217496
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K002877 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Lumen/Inner Diameter | 4.5 | Millimeter | |
| Length | 300 | Millimeter |