FDA UDI
In Commercial Distribution
🇺🇸 United States
Endodrill Biopsy instrument
DI: 17340179900054
·
Model: GI 17G
·
Bibbinstruments AB
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Endodrill Biopsy instrument
- Primary DI
- 17340179900054
- Version / Model
- GI 17G
- Catalog Number
- 1005-40
- Company Name
- Bibbinstruments AB
- Labeler DUNS
- 352499168
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-01-31
- Public Version
- 1
- Public Version Date
- 2024-02-08
- Public Version Status
- New
- Public Device Record Key
- 5592c064-0f90-45c9-9dd3-2ab07ac4a889
Device Description
Sterile single use biopsi instrument GI to be used with Endodrill drive system. The EndoDrill® GI is a surgical instrument intended to collect tissue for histological examination through a flexible endoscope.
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
- No
- 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
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FCG | Biopsy Needle | Gastroenterology, Urology | 876.1075 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38825 | General-purpose endoscopic needle, single-use | A flexible, sterile, sharp bevel-edged, hollow tubular device intended to be manually-operated through a compatible endoscope to perform various needle functions (e.g., injection, aspiration, irrigation, puncture) during endoscopy. It is designed with appropriate shape, materials, gauge, and other characteristics (e.g., high-contrast tips) to function through the working channel of an endoscope. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 17340179900054 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K212423 | 000 |