Primary Device ID | E203USPB41511 |
NIH Device Record Key | de1894f7-e739-4fef-b90a-b3f87ea0a242 |
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 Issuing Agency | Device ID |
---|---|
HIBCC | E203USPB41511 [Primary] |
GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2019-04-08 |
Device Publish Date | 2019-01-17 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() GLYCOLON 79182634 5024698 Live/Registered |
Resorba Medical GmbH 2016-01-12 |