Primary Device ID | D795112 |
NIH Device Record Key | bd4fd482-7b1a-43ba-8165-22f360fb0ee0 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | GluStitch® Twist |
Version Model Number | GLTWI05 |
Catalog Number | GLTWI05 |
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 | true |
OTC Over-The-Counter | false |
Phone | 1-877-940-2262 |
info@glustitch.com | |
Phone | 1-877-940-2262 |
info@glustitch.com |
Device Issuing Agency | Device ID |
---|---|
HIBCC | D795110 [Primary] |
HIBCC | D795111 [Package] Contains: D795110 Package: BOX [6 Units] In Commercial Distribution |
HIBCC | D795112 [Package] Contains: D795110 Package: BOX [12 Units] In Commercial Distribution |
MPN | Tissue Adhesive For The Topical Approximation Of Skin |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2017-02-07 |
D795122 | GluStitch Twist Tissue Adhesive is a sterile, topical tissue adhesive containing n-butyl-2-cyano |
D795112 | GluStitch Twist Tissue Adhesive is a sterile, topical tissue adhesive containing n-butyl-2-cyano |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
GLUSTITCH 75443544 2266640 Live/Registered |
Blacklock Medical Products Inc. 1998-03-03 |