GluSeal® GLUSEAL5C
GUDID D795161
GluSeal® 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 | D795161 |
| NIH Device Record Key | 48dc3655-8956-4d7a-bf10-68febd166b61 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GluSeal® |
| Version Model Number | GLUSEAL5C |
| Catalog Number | GLUSEAL5C |
| 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 | true |
| Device Combination Product | false |
| Single Use | false |
| 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 | D795161 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K030574
FDA Product Code
| KMF | Bandage, Liquid |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
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®]
| D795210 | GluSeal® liquid adhesive bandage is intended to cover minor cuts, scrapes, burns, and minor irr |
| D795201 | GluSeal® liquid adhesive bandage is intended to cover minor cuts, scrapes, burns, and minor irr |
| D795191 | GluSeal® liquid adhesive bandage is intended to cover minor cuts, scrapes, burns, and minor irr |
| D795183 | GluSeal® liquid adhesive bandage is intended to cover minor cuts, scrapes, burns, and minor irr |
| D795173 | GluSeal® liquid adhesive bandage is intended to cover minor cuts, scrapes, burns, and minor irr |
| D795161 | GluSeal® liquid adhesive bandage is intended to cover minor cuts, scrapes, burns, and minor irr |
| D795151 | GluSeal® liquid adhesive bandage is intended to cover minor cuts, scrapes, burns, and minor irr |
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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