FDA UDI
In Commercial Distribution
🇺🇸 United States
Titanium rib clip, right, 45°, Standard
DI: 04260029580822
·
Model: 012-02450
·
MedXpert GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Titanium rib clip, right, 45°, Standard
- Primary DI
- 04260029580822
- Version / Model
- 012-02450
- Catalog Number
- 012-02450
- 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
- 854bd4b2-89ff-4cb1-8e80-52137d4a1942
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
- 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
- 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 |
|---|---|---|---|---|
| HRS | Plate, Fixation, Bone | Orthopedic | 888.3030 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58339 | Rib/rib cage internal fixation/bracing system fixation grip/anchor | A non-sterile implantable device designed to be clasped around a rib and to connect bracing bars for bridging congenital or postsurgical deficits in the rib cage. It typically consists of a narrow plate with pairs of fenestrated gripping arms and a straight or angled holding arm for attachment (anchoring) of a bracing bar; it is made of metal [e.g., titanium (Ti)]. It can be surgically removed when required or remain in situ. This device must be sterilized prior to use. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04260029580822 | GS1 |
Customer Contacts
- Phone
- +4976345085630
- [email protected]