FDA UDI
In Commercial Distribution
🇺🇸 United States
mahe medical GmbH
DI: 04050659369696
·
Model: 35.010.095SR
·
mahe medical gmbh
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- mahe medical GmbH
- Primary DI
- 04050659369696
- Version / Model
- 35.010.095SR
- 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
- 9ca924b8-b24d-4134-bf5c-83934299febf
Device Description
Scissors, single action _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 |
|---|---|---|---|---|
| GCJ | Laparoscope, general & plastic surgery | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46421 | Rigid endoscopic scissors, reusable | A hand-held rigid device used in combination with a dedicated endoscope and intended to cut tissue or sutures during an endoscopic procedure. It is typically constructed of stainless steel and is designed as a long pair of parallel sliding arms whose distal end is equipped with a pair of mechanical (i.e., not electrosurgical) cutting blades operated through a ringed handle at the proximal end. It is typically introduced into the body cavity through 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 | 04050659369696 | GS1 |