FDA UDI
In Commercial Distribution
🇺🇸 United States
mahe medical GmbH
DI: 04050659368934
·
Model: 35.010.015SR
·
mahe medical gmbh
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- mahe medical GmbH
- Primary DI
- 04050659368934
- Version / Model
- 35.010.015SR
- Company Name
- mahe medical gmbh
- Labeler DUNS
- 342243334
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-11-05
- Public Version
- 1
- Public Version Date
- 2019-11-13
- Public Version Status
- New
- Public Device Record Key
- a513709a-7a43-497b-b26a-c9e7e1b42a40
Device Description
Foreign body fcps.,alligator _x000D_5Fr.,400mm, semi-rigid _x000D_
Device Characteristics
- Single Use
- Yes
- 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
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- Yes
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
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 |
|---|---|---|---|---|
| 38661 | Rigid endoscopic grasping forceps, reusable | A rigid hand-held, manual device used in combination with a compatible endoscope to grasp tissue (typically atraumatically) or foreign bodies. It is typically constructed as a very long instrument with one sliding and one stationary rod whose distal ends are equipped with grasping tongs or claws which are operated by scissors-like ring handles at the proximal end of the instrument; it is not an electrosurgical instrument. It is typically made of high-grade stainless steel and is introduced into the body through the working channel of the endoscope to grasp internal structures for observation, excision, and/or biopsy procedures. This is a reusable device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04050659368934 | GS1 |