Osseofit™ Porous Tissue Matrix 50604-10
GUDID 00812337021548
DSM BIOMEDICAL, INC.
Composite bone graft Composite bone graft Composite bone graft Composite bone graft Composite bone graft Composite bone graft Composite bone graft Composite bone graft Composite bone graft Composite bone graft Composite bone graft Composite bone graft Composite bone graft Composite bone graft Composite bone graft Composite bone graft Composite bone graft Composite bone graft Bone matrix implant, composite Bone matrix implant, composite Bone matrix implant, composite Bone matrix implant, composite Bone matrix implant, composite Bone matrix implant, composite Bone matrix implant, composite Bone matrix implant, composite Bone matrix implant, composite Bone matrix implant, composite Bone matrix implant, composite Bone matrix implant, composite Bone matrix implant, composite Bone matrix implant, composite Bone matrix implant, composite| Primary Device ID | 00812337021548 |
| NIH Device Record Key | e6c2c8ae-7832-4798-9ac8-1f14eafaaab1 |
| Commercial Distribution Discontinuation | 2019-09-30 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Osseofit™ Porous Tissue Matrix |
| Version Model Number | 50604-10 |
| Catalog Number | 50604-10 |
| Company DUNS | 131107757 |
| Company Name | DSM BIOMEDICAL, INC. |
| 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
| Circumference | 10 Millimeter |
| Circumference | 10 Millimeter |
| Circumference | 10 Millimeter |
| Circumference | 10 Millimeter |
| Circumference | 10 Millimeter |
| Circumference | 10 Millimeter |
| Circumference | 10 Millimeter |
| Circumference | 10 Millimeter |
| Circumference | 10 Millimeter |
| Circumference | 10 Millimeter |
| Circumference | 10 Millimeter |
| Circumference | 10 Millimeter |
| Circumference | 10 Millimeter |
| Circumference | 10 Millimeter |
| Circumference | 10 Millimeter |
| Circumference | 10 Millimeter |
| Circumference | 10 Millimeter |
| Circumference | 10 Millimeter |
| Circumference | 10 Millimeter |
| Circumference | 10 Millimeter |
| Circumference | 10 Millimeter |
| Circumference | 10 Millimeter |
| Circumference | 10 Millimeter |
| Circumference | 10 Millimeter |
| Circumference | 10 Millimeter |
| Circumference | 10 Millimeter |
| Circumference | 10 Millimeter |
| Circumference | 10 Millimeter |
| Circumference | 10 Millimeter |
| Circumference | 10 Millimeter |
| Circumference | 10 Millimeter |
| Circumference | 10 Millimeter |
| Circumference | 10 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00812337021548 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K060917
FDA Product Code
| MQV | Filler, Bone Void, Calcium Compound |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-10-01 |
| Device Publish Date | 2015-09-01 |
On-Brand Devices [Osseofit™ Porous Tissue Matrix]
| 00812337021562 | 50604-15 |
| 00812337021555 | 50604-12 |
| 00812337021548 | 50604-10 |
| 00812337021531 | 50604-08 |
| 00812337021524 | 50604-06 |
| 00812337021517 | 50604-04 |
Trademark Results [Osseofit]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OSSEOFIT 97924878 not registered Live/Pending |
Zimmer, Inc. 2023-05-08 |
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