FDA UDI
In Commercial Distribution
🇺🇸 United States
Semi-Flexible Biopsy Forceps, up-biting
DI: 04250337110569
·
Model: JFBF322541U
·
Joimax GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Semi-Flexible Biopsy Forceps, up-biting
- Primary DI
- 04250337110569
- Version / Model
- JFBF322541U
- Company Name
- Joimax GmbH
- Labeler DUNS
- 344267187
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-03-17
- Public Version
- 1
- Public Version Date
- 2025-03-25
- Public Version Status
- New
- Public Device Record Key
- 1b7ef4cf-474a-4e74-b7a7-92b162ab14f7
Device Description
Forceps are used during minimally invasive spinal surgery for the removal of soft tissue, loose tissue fragments and herniated disc material by grasping and cutting the material. Usually, they are inserted through the working channel of an endoscope. With clear orientation, bigger fragments of tissue can be removed without an endoscope directly through the working tube under X-ray control.
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
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| GEN | Forceps, General & Plastic Surgery | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38810 | Flexible endoscopic biopsy forceps, reusable | A flexible, manual, non-electrosurgical instrument intended to obtain tissue specimens during endoscopic procedures (e.g., gastro-urological endoscopy, laparoscopy, bronchoscopy, laryngoscopy) for histopathological examination. It is typically a flexible metal coil with a pair of scissors-like cups with cutting edge rims, which are operated by a control handle at the proximal end of the instrument. It is introduced into the body through an artificial orifice of the body or the working channel of the endoscope. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04250337110569 | GS1 |