EpiGuide® Bioresorbable Barrier Matrix 50600-02
GUDID 00812337027137
DSM BIOMEDICAL, INC.
Pliable-polymer dental regeneration membrane, bioabsorbable, tacked| Primary Device ID | 00812337027137 |
| NIH Device Record Key | 8af1275e-65f4-4d42-a9a5-59933e543b61 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EpiGuide® Bioresorbable Barrier Matrix |
| Version Model Number | 50600-02 |
| Catalog Number | 50600-02 |
| 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 | true |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Device Dimensions
| Width | 18 Millimeter |
| Width | 18 Millimeter |
| Width | 18 Millimeter |
| Width | 18 Millimeter |
| Length | 30 Millimeter |
| Width | 18 Millimeter |
| Length | 30 Millimeter |
| Width | 18 Millimeter |
| Length | 30 Millimeter |
| Width | 18 Millimeter |
| Length | 30 Millimeter |
| Width | 18 Millimeter |
| Length | 30 Millimeter |
| Width | 18 Millimeter |
| Length | 30 Millimeter |
| Width | 18 Millimeter |
| Length | 30 Millimeter |
| Width | 18 Millimeter |
| Length | 30 Millimeter |
| Width | 18 Millimeter |
| Length | 30 Millimeter |
| Width | 18 Millimeter |
| Length | 30 Millimeter |
| Width | 18 Millimeter |
| Length | 30 Millimeter |
| Width | 18 Millimeter |
| Length | 30 Millimeter |
| Width | 18 Millimeter |
| Length | 30 Millimeter |
| Width | 18 Millimeter |
| Length | 30 Millimeter |
| Width | 18 Millimeter |
| Length | 30 Millimeter |
| Width | 18 Millimeter |
| Length | 30 Millimeter |
| Width | 18 Millimeter |
| Length | 30 Millimeter |
| Width | 18 Millimeter |
| Length | 30 Millimeter |
| Width | 18 Millimeter |
| Length | 30 Millimeter |
| Width | 18 Millimeter |
| Length | 30 Millimeter |
| Width | 18 Millimeter |
| Length | 30 Millimeter |
| Width | 18 Millimeter |
| Length | 30 Millimeter |
| Width | 18 Millimeter |
| Length | 30 Millimeter |
| Width | 18 Millimeter |
| Length | 30 Millimeter |
| Width | 18 Millimeter |
| Length | 30 Millimeter |
| Width | 18 Millimeter |
| Length | 30 Millimeter |
| Width | 18 Millimeter |
| Length | 30 Millimeter |
| Width | 18 Millimeter |
| Length | 30 Millimeter |
| Width | 18 Millimeter |
| Length | 30 Millimeter |
| Width | 18 Millimeter |
| Length | 30 Millimeter |
| Width | 18 Millimeter |
| Length | 30 Millimeter |
| Width | 18 Millimeter |
| Length | 30 Millimeter |
| Width | 18 Millimeter |
| Length | 30 Millimeter |
| Width | 18 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00812337027137 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K940643
FDA Product Code
| LYC | Bone Grafting Material, Synthetic |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-02-13 |
| Device Publish Date | 2015-09-04 |
On-Brand Devices [EpiGuide® Bioresorbable Barrier Matrix ]
| 00812337027137 | 50600-02 |
| 00812337027144 | 50600-03 |
Trademark Results [EpiGuide]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 EPIGUIDE 86106576 4775063 Live/Registered |
Episurf IP-Management AB 2013-10-31 |
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