GluSeal®90 GLUSEAL(ST)
GUDID D795130
GluSeal®90 liquid adhesive bandage is intended to cover minor cuts, scrapes, burns, and minor irritations of the skin and help protect them from infection.
Glustich Inc
Skin-approximation adhesive| Primary Device ID | D795130 |
| NIH Device Record Key | 0e7d2b83-eef1-427c-b5d4-83036cb88eac |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GluSeal®90 |
| Version Model Number | GLUSEAL(ST) |
| Catalog Number | GLUSEAL(ST) |
| Company DUNS | 201637158 |
| Company Name | Glustich 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 | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 1-877-940-2262 |
| info@glustitch.com | |
| Phone | 1-877-940-2262 |
| info@glustitch.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D795130 [Primary] |
| HIBCC | D795133 [Package] Package: BOX [12 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K083752
FDA Product Code
| KMF | Bandage, Liquid |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-04-07 |
On-Brand Devices [GluSeal®90]
| D795220 | GluSeal®90 liquid adhesive bandage is intended to cover minor cuts, scrapes, burns, and minor i |
| D795143 | GluSeal®90 liquid adhesive bandage is intended to cover minor cuts, scrapes, burns, and minor i |
| D795130 | GluSeal®90 liquid adhesive bandage is intended to cover minor cuts, scrapes, burns, and minor i |
Trademark Results [GluSeal]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GLUSEAL 78186551 2898127 Live/Registered |
GluStitch Inc. 2002-11-19 |
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