FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Precisor
DI: 30653405052054
·
Model: 000823
·
Conmed Corporation
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
10
Basic Information
- Brand Name
- Precisor
- Primary DI
- 30653405052054
- Version / Model
- 000823
- Catalog Number
- 000823
- Company Name
- Conmed Corporation
- Labeler DUNS
- 071595540
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2020-11-28
- Public Version
- 2
- Public Version Date
- 2022-06-07
- Public Version Status
- Update
- Public Device Record Key
- 4f6e3f3b-c925-40b7-9ca6-e1c2841e18ca
- Distribution End Date
- 2022-06-06
Device Description
Precisor Jumbo Disposable Biopsy Forceps
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FCL | FORCEPS, BIOPSY, NON-ELECTRIC | Gastroenterology, Urology | 876.1075 | 1 |
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 |
|---|---|---|---|---|---|---|
| Package | 10653405052050 | GS1 | BOX | 10 | Not in Commercial Distribution | 2022-06-06 |
| Primary | 30653405052054 | GS1 | ||||
| Unit of Use | 00653405052053 | GS1 |
Customer Contacts
- Phone
- +1(866)426-6633
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Depth | 3.8 | Millimeter | |
| Length | 230 | Centimeter | |
| Width | 3.1 | Millimeter |