Geistlich Derma-Gide™
GUDID 07610221013197
Geistlich Pharma AG
Collagen wound matrix dressing| Primary Device ID | 07610221013197 |
| NIH Device Record Key | 50d66528-f397-4100-9a38-b79186b06072 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Geistlich Derma-Gide™ |
| Version Model Number | 500477 |
| Company DUNS | 480781728 |
| Company Name | Geistlich Pharma AG |
| 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 |
Device Dimensions
| Outer Diameter | 12 Millimeter |
| Outer Diameter | 12 Millimeter |
| Outer Diameter | 12 Millimeter |
| Outer Diameter | 12 Millimeter |
| Outer Diameter | 12 Millimeter |
| Outer Diameter | 12 Millimeter |
| Outer Diameter | 12 Millimeter |
| Outer Diameter | 12 Millimeter |
| Outer Diameter | 12 Millimeter |
| Outer Diameter | 12 Millimeter |
| Outer Diameter | 12 Millimeter |
| Outer Diameter | 12 Millimeter |
| Outer Diameter | 12 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07610221013197 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K182838
FDA Product Code
| KGN | Dressing, Wound, Collagen |
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 | 2020-05-06 |
| Device Publish Date | 2019-01-31 |
On-Brand Devices [Geistlich Derma-Gide™]
| 07610221013227 | 500480 |
| 07610221013210 | 500479 |
| 07610221013203 | 500478 |
| 07610221013197 | 500477 |
| 07610221013180 | 500476 |
| 07610221013173 | 500475 |
| 07610221013166 | 500474 |
| 07610221012626 | 500427 |
| 07610221012619 | 500426 |
| 07610221012602 | 500425 |
Trademark Results [Geistlich Derma-Gide]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GEISTLICH DERMA-GIDE 87778500 5555339 Live/Registered |
Geistlich Pharma AG 2018-01-31 |
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