Identity
- Trade Name
- GluStitch® Twist FDA UDI
- Generic Name
- Skin-approximation adhesive FDA UDI
- Device Name
- GluStitch Twist Tissue Adhesive is a sterile, topical tissue adhesive containing n-butyl-2-cyanoacrylate. GluStitch Twist Tissue Adhesive is supplied in a single patient use, twist-and-use ampoule that contains at least 0.5g of liquid tissue adhesive. GluStitch Twist Tissue Adhesive is intended for the topical closure of surgical skin incisions and trauma-induced lacerations in areas of low skin tension that are simple, thoroughly-cleansed, and have easily approximated skin edges. GluStitch Twist may be used in conjunction with, but not in place of, deep dermal stitches. FDA UDI
- Model / Reference
- GLTWI05 FDA UDI
- Description
- GluStitch Twist Tissue Adhesive is a sterile, topical tissue adhesive containing n-butyl-2-cyanoacrylate. GluStitch Twist Tissue Adhesive is supplied in a single patient use, twist-and-use ampoule that contains at least 0.5g of liquid tissue adhesive. GluStitch Twist Tissue Adhesive is intended for the topical closure of surgical skin incisions and trauma-induced lacerations in areas of low skin tension that are simple, thoroughly-cleansed, and have easily approximated skin edges. GluStitch Twist may be used in conjunction with, but not in place of, deep dermal stitches. FDA UDI
Identifiers
- Catalog Number
- GLTWI05 FDA UDI
- Primary DI / UDI-DI
- D795110 FDA UDI
- 510(k) Number
- K150032 FDA UDI
- FDA Product Code
- MPN FDA UDI
- GMDN Term
- Skin-approximation adhesive FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4010 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Skin-approximation adhesive
GluStitch® Twist by Glustich Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Skin-approximation adhesive.
- Tissue Seal — TISSUE SEAL L.L.C. · Class II
- LiquiBand Octyl Mini — Advanced Medical Solutions (Plymouth), Ltd. · Class II
- Henry Schein — HENRY SCHEIN, INC. · Class II
- Medichoice — OWENS & MINOR DISTRIBUTION, INC. · Class II
- LiquiBand Flow Control — Advanced Medical Solutions (Plymouth), Ltd. · Class II
- Tissue Seal — TISSUE SEAL L.L.C. · Class II
- Topical Skin Adhesive — Covidien LP · Class II
- exofin SC — CHEMENCE MEDICAL INC. · Class II
Cleared under the same submission
K150032 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Glustich Inc
Sources (1)
- FDA UDI bd4fd482-7b1a-43ba-8165-22f360fb0ee0 36 fields · synced May 30, 2026