GLYCOLON
GUDID E203USPB41528
Resorba Medical GmbH
Polyglyconate suture| Primary Device ID | E203USPB41528 |
| NIH Device Record Key | 9fbef7ea-1fed-435c-9ef4-099655e412ab |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GLYCOLON |
| Version Model Number | GLYCOLON |
| Company DUNS | 341053195 |
| Company Name | Resorba Medical 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 | true |
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | E203USPB41528 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K143584
FDA Product Code
| GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid |
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 | 2019-04-08 |
| Device Publish Date | 2019-01-17 |
On-Brand Devices [GLYCOLON]
Trademark Results [GLYCOLON]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GLYCOLON 79182634 5024698 Live/Registered |
Resorba Medical GmbH 2016-01-12 |
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