FDA UDI
In Commercial Distribution
🇺🇸 United States
Implant cutting pliers with exchangeable jaw inserts, narrow, 22 cm
DI: 04260029580648
·
Model: 010-00011
·
MedXpert GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Implant cutting pliers with exchangeable jaw inserts, narrow, 22 cm
- Primary DI
- 04260029580648
- Version / Model
- 010-00011
- Catalog Number
- 010-00011
- Company Name
- MedXpert GmbH
- Labeler DUNS
- 331019344
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-01-05
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 096bbcb5-d523-423f-b9d8-db6b5f257667
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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| MDM | Instrument, Manual, Surgical, General Use | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58342 | Rib/rib cage internal fixation/bracing system cutting pliers | A hand-held manual surgical instrument designed to be used with a rib/rib cage internal fixation/bracing system for cutting the rib grip or bracing bar implants to a specific size. The instrument is typically made of high-grade steel and consists of two pivoted or multi-pivoted handles that form a handle proximally and when squeezed together, close the jaws distally to bite (cut) through the metal implants. It typically will have replaceable blades. This is a reusable device intended to be sterilized prior to use. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04260029580648 | GS1 |
Customer Contacts
- Phone
- +4976345085630
- [email protected]