OsteoBridge™ IDSF Diaphysis Tibial Nail GB41207S
GUDID 04048266166708
Merete GmbH
Diaphysis prosthesis| Primary Device ID | 04048266166708 |
| NIH Device Record Key | 671717b8-28d3-473a-84df-cf66ff7892a1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OsteoBridge™ IDSF Diaphysis Tibial Nail |
| Version Model Number | 12 70 |
| Catalog Number | GB41207S |
| Company DUNS | 313267265 |
| Company Name | Merete GmbH |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Dimensions
| Outer Diameter | 12 Millimeter |
| Length | 70 Millimeter |
| Outer Diameter | 12 Millimeter |
| Length | 70 Millimeter |
| Outer Diameter | 12 Millimeter |
| Length | 70 Millimeter |
| Outer Diameter | 12 Millimeter |
| Length | 70 Millimeter |
| Outer Diameter | 12 Millimeter |
| Length | 70 Millimeter |
| Outer Diameter | 12 Millimeter |
| Length | 70 Millimeter |
| Outer Diameter | 12 Millimeter |
| Length | 70 Millimeter |
| Outer Diameter | 12 Millimeter |
| Length | 70 Millimeter |
| Outer Diameter | 12 Millimeter |
| Length | 70 Millimeter |
| Outer Diameter | 12 Millimeter |
| Length | 70 Millimeter |
| Outer Diameter | 12 Millimeter |
| Length | 70 Millimeter |
| Outer Diameter | 12 Millimeter |
| Length | 70 Millimeter |
| Outer Diameter | 12 Millimeter |
| Length | 70 Millimeter |
| Outer Diameter | 12 Millimeter |
| Length | 70 Millimeter |
| Outer Diameter | 12 Millimeter |
| Length | 70 Millimeter |
| Outer Diameter | 12 Millimeter |
| Length | 70 Millimeter |
| Outer Diameter | 12 Millimeter |
| Length | 70 Millimeter |
| Outer Diameter | 12 Millimeter |
| Length | 70 Millimeter |
| Outer Diameter | 12 Millimeter |
| Length | 70 Millimeter |
| Outer Diameter | 12 Millimeter |
| Length | 70 Millimeter |
| Outer Diameter | 12 Millimeter |
| Length | 70 Millimeter |
| Outer Diameter | 12 Millimeter |
| Length | 70 Millimeter |
| Outer Diameter | 12 Millimeter |
| Length | 70 Millimeter |
| Outer Diameter | 12 Millimeter |
| Length | 70 Millimeter |
| Outer Diameter | 12 Millimeter |
| Length | 70 Millimeter |
| Outer Diameter | 12 Millimeter |
| Length | 70 Millimeter |
| Outer Diameter | 12 Millimeter |
| Length | 70 Millimeter |
| Outer Diameter | 12 Millimeter |
| Length | 70 Millimeter |
| Outer Diameter | 12 Millimeter |
| Length | 70 Millimeter |
| Outer Diameter | 12 Millimeter |
| Length | 70 Millimeter |
| Outer Diameter | 12 Millimeter |
| Length | 70 Millimeter |
| Outer Diameter | 12 Millimeter |
| Length | 70 Millimeter |
| Outer Diameter | 12 Millimeter |
| Length | 70 Millimeter |
| Outer Diameter | 12 Millimeter |
| Length | 70 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04048266166708 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K181026
FDA Product Code
| HSB | Rod, Fixation, Intramedullary And Accessories |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2023-05-08 |
| Device Publish Date | 2018-10-31 |
On-Brand Devices [OsteoBridge™ IDSF Diaphysis Tibial Nail]
| 04048266166791 | 14 200 |
| 04048266166784 | 14 150 |
| 04048266166777 | 14 130 |
| 04048266166760 | 14 110 |
| 04048266166753 | 14 90 |
| 04048266166746 | 12 130 |
| 04048266166739 | 12 150 |
| 04048266166722 | 12 110 |
| 04048266166715 | 12 90 |
| 04048266166708 | 12 70 |
| 04048266166692 | 10 130 |
| 04048266166685 | 10 110 |
| 04048266166678 | 10 90 |
| 04048266166661 | 10 70 |
| 04048266166654 | 10 60 |
| 04048266166647 | 9 90 |
| 04048266166630 | 9 70 |
| 04048266166623 | 9 60 |
Trademark Results [OsteoBridge]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OSTEOBRIDGE 86180106 4636001 Live/Registered |
ARISTOTECH INDUSTRIES GMBH 2014-01-30 |
 OSTEOBRIDGE 77009670 3354525 Dead/Cancelled |
ARISTOTECH INDUSTRIES GMBH 2006-09-28 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.