FDA UDI
In Commercial Distribution
🇺🇸 United States
ROTO TISCHLER BIOPSY PUNCH 10"
DI: G422BP1090
·
Model: BP109
·
BIOPSY FINE CUT INSTRUMENTS
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- ROTO TISCHLER BIOPSY PUNCH 10"
- Primary DI
- G422BP1090
- Version / Model
- BP109
- Catalog Number
- BP109
- Company Name
- BIOPSY FINE CUT INSTRUMENTS
- Labeler DUNS
- 645680898
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-10-13
- Public Version
- 1
- Public Version Date
- 2023-10-23
- Public Version Status
- New
- Public Device Record Key
- 97fc11ea-24b9-4432-94d8-a013e4cbc315
Device Description
ROTO TISCHLER BIOPSY PUNCH 10" UP, COMPLETE SET HANDLE+TIP
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- No
- 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
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HFB | Forceps, Biopsy, Gynecological | Obstetrics/Gynecology | 884.4530 | 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 | G422BP1091 | HIBCC | Mini Box | 2 | In Commercial Distribution | |
| Primary | G422BP1090 | HIBCC |