Primary Device ID | 07898616351431 |
NIH Device Record Key | d61d517c-a448-4c78-a133-8b38918a23ad |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | OstomyGel |
Version Model Number | 290010003 |
Catalog Number | 290010003 |
Company DUNS | 904563269 |
Company Name | DMC IMPORTACAO E EXPORTACAO DE EQUIPAMENTOS LTDA |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
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 | false |
OTC Over-The-Counter | true |
Device Issuing Agency | Device ID |
---|---|
GS1 | 07898616351431 [Primary] |
GDS | Bag, Stomal |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2025-05-06 |
Device Publish Date | 2025-04-28 |
07898616351431 - OstomyGel | 2025-05-06Ostomy accessory |
07898616351431 - OstomyGel | 2025-05-06 Ostomy accessory |
07898616351400 - e-light I-US | 2025-03-13 Laser system for therapy |
07898616351417 - e-light B-US | 2025-03-13 Heat source for bleaching teeth |
07898616351424 - e-light V-US | 2025-03-13 Heat source for bleaching teeth |
07898616351127 - Therapy EC (FDA) | 2025-01-29 Laser system for therapy |
07898616351134 - Therapy XT (FDA) | 2025-01-29 Laser system for therapy |