OsteoBridge™ IDSF Diaphysis Tibial Spacer GB60014S
GUDID 04048266179845
Merete GmbH
Diaphysis prosthesis| Primary Device ID | 04048266179845 |
| NIH Device Record Key | afa5e433-5e6a-4c1e-856e-3304376cc809 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OsteoBridge™ IDSF Diaphysis Tibial Spacer |
| Version Model Number | 25 70 |
| Catalog Number | GB60014S |
| 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 | 25 Millimeter |
| Length | 70 Millimeter |
| Outer Diameter | 25 Millimeter |
| Length | 70 Millimeter |
| Outer Diameter | 25 Millimeter |
| Length | 70 Millimeter |
| Outer Diameter | 25 Millimeter |
| Length | 70 Millimeter |
| Outer Diameter | 25 Millimeter |
| Length | 70 Millimeter |
| Outer Diameter | 25 Millimeter |
| Length | 70 Millimeter |
| Outer Diameter | 25 Millimeter |
| Length | 70 Millimeter |
| Outer Diameter | 25 Millimeter |
| Length | 70 Millimeter |
| Outer Diameter | 25 Millimeter |
| Length | 70 Millimeter |
| Outer Diameter | 25 Millimeter |
| Length | 70 Millimeter |
| Outer Diameter | 25 Millimeter |
| Length | 70 Millimeter |
| Outer Diameter | 25 Millimeter |
| Length | 70 Millimeter |
| Outer Diameter | 25 Millimeter |
| Length | 70 Millimeter |
| Outer Diameter | 25 Millimeter |
| Length | 70 Millimeter |
| Outer Diameter | 25 Millimeter |
| Length | 70 Millimeter |
| Outer Diameter | 25 Millimeter |
| Length | 70 Millimeter |
| Outer Diameter | 25 Millimeter |
| Length | 70 Millimeter |
| Outer Diameter | 25 Millimeter |
| Length | 70 Millimeter |
| Outer Diameter | 25 Millimeter |
| Length | 70 Millimeter |
| Outer Diameter | 25 Millimeter |
| Length | 70 Millimeter |
| Outer Diameter | 25 Millimeter |
| Length | 70 Millimeter |
| Outer Diameter | 25 Millimeter |
| Length | 70 Millimeter |
| Outer Diameter | 25 Millimeter |
| Length | 70 Millimeter |
| Outer Diameter | 25 Millimeter |
| Length | 70 Millimeter |
| Outer Diameter | 25 Millimeter |
| Length | 70 Millimeter |
| Outer Diameter | 25 Millimeter |
| Length | 70 Millimeter |
| Outer Diameter | 25 Millimeter |
| Length | 70 Millimeter |
| Outer Diameter | 25 Millimeter |
| Length | 70 Millimeter |
| Outer Diameter | 25 Millimeter |
| Length | 70 Millimeter |
| Outer Diameter | 25 Millimeter |
| Length | 70 Millimeter |
| Outer Diameter | 25 Millimeter |
| Length | 70 Millimeter |
| Outer Diameter | 25 Millimeter |
| Length | 70 Millimeter |
| Outer Diameter | 25 Millimeter |
| Length | 70 Millimeter |
| Outer Diameter | 25 Millimeter |
| Length | 70 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04048266179845 [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 Spacer]
| 04048266179845 | 25 70 |
| 04048266179838 | 25 60 |
| 04048266179821 | 25 50 |
| 04048266179814 | 25 40 |
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 |
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