FDA UDI
In Commercial Distribution
🇺🇸 United States
OsteoBridge™ IDSF Diaphysis Humeral Nail
DI: 04048266166487
·
Model: 8 60
·
Merete GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- OsteoBridge™ IDSF Diaphysis Humeral Nail
- Primary DI
- 04048266166487
- Version / Model
- 8 60
- Catalog Number
- GB80806S
- Company Name
- Merete GmbH
- Labeler DUNS
- 313267265
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-10-31
- Public Version
- 3
- Public Version Date
- 2023-05-12
- Public Version Status
- Update
- Public Device Record Key
- 48a5cfed-cbe0-4e66-b7c4-e1098b6184d8
Device Description
OsteoBridge™ IDSF Diaphysis Humeral Nail 8 60 Connection D: 10 TiAl6V4 ELI sterile
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
- No
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HSB | Rod, Fixation, Intramedullary And Accessories | Orthopedic | 888.3020 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58084 | Diaphysis prosthesis | An artificial substitute for the diaphysis (shaft) of a humerus, femur, or tibia intended to be implanted for the long-term stabilization of segmental bone defects (e.g., due to osteomyelitis, trauma, bone tumours, or non-healed fractures after osteosynthesis/revision arthroplasty). It is a modular device that typically includes a resection element (spacer), intramedullary nails (inserted into the intramedullary canal), screws, and connectors all made of metal [e.g., titanium (Ti)]; components are both sterile and non-sterile. Instruments for implantation are typically included and implantation may be performed with or without bone cement. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04048266166487 | GS1 |
Customer Contacts
- Phone
- +1(630)869-1092
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K181026 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 8 | Millimeter | |
| Length | 60 | Millimeter |