DEVICE: GluSeal®90 (D795130)
Device Identifier (DI) Information
GluSeal®90
GLUSEAL(ST)
In Commercial Distribution
GLUSEAL(ST)
Glustich Inc
GLUSEAL(ST)
In Commercial Distribution
GLUSEAL(ST)
Glustich Inc
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.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
34164 | Skin-approximation adhesive |
A sterile biodegradable glue made of synthetic polymer (e.g., cyanoacrylate) intended for topical closure of surgical incisions and simple traumatic lacerations that have easily-approximated skin edges; it is not intended for internal surgical applications. After application, this device cannot be reused.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KMF | Bandage, Liquid |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K083752 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
0e7d2b83-eef1-427c-b5d4-83036cb88eac
July 06, 2018
3
April 07, 2017
July 06, 2018
3
April 07, 2017
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
D795133 | 12 | D795130 | In Commercial Distribution | BOX |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
1-877-940-2262
info@glustitch.com
info@glustitch.com