FDA UDI
In Commercial Distribution
🇺🇸 United States
Arthroscopy trocar,blunt,OD 4.2mm, HIGH-FLOW,f.optics 4.0/176mm
DI: EMAH50036050
·
Model: 50.036.05
·
mahe medical gmbh
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Arthroscopy trocar,blunt,OD 4.2mm, HIGH-FLOW,f.optics 4.0/176mm
- Primary DI
- EMAH50036050
- Version / Model
- 50.036.05
- Catalog Number
- 50.036.05
- Company Name
- mahe medical gmbh
- Labeler DUNS
- 342243334
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-03
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- ce881d67-7871-499a-bf34-dac8368fcafa
Device Description
Arthroscopy trocar,blunt,OD 4.2mm, HIGH-FLOW,f.optics 4.0/176mm
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- 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
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NBH | ACCESSORIES,ARTHROSCOPIC | Orthopedic | 888.1100 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47457 | Orthopaedic trocar blade, reusable | A rigid hand-held surgical instrument with a sharp (pyramidal or conical) point designed to be used during orthopaedic surgery for the manual puncture of a bodily entry point to: 1) gently part the surrounding soft tissue upon entry; 2) assist in the location and positioning of skeletal fractures; and/or 3) assist alignment of surgical instruments/implants. It is typically made of high-grade stainless steel, titanium (Ti), or synthetic material. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | EMAH50036051 | HIBCC | 1 | In Commercial Distribution | ||
| Primary | EMAH50036050 | HIBCC |
Customer Contacts
- Phone
- +49(0)746592750
- [email protected]