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Sign in to claim this brandGlustich Inc
US
Last updated May 27, 2026
What Glustich Inc makes
Glustich Inc manufactures skin-approximation adhesives and clinical periodontal dressings, including products like GluSeal® and PeriAcryl®. These devices are designed for wound closure and periodontal treatment, with some formulations incorporating adhesive technology for tissue approximation. The company also produces GluStitch® Twist, a device for securing skin or soft tissue edges during surgical procedures.
The company’s products are classified under FDA’s Class I and Class II categories, with listings maintained in the FDA’s Unique Device Identifier (UDI) database. These devices are subject to regulatory oversight under the US Food and Drug Administration’s medical device regulations, ensuring compliance with applicable standards for safety and performance.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Glustich Inc manufacture?
Glustich Inc specializes in two primary categories of medical devices: skin-approximation adhesives and clinical periodontal dressings. Skin-approximation adhesives, like the GluSeal® series, are designed to close wounds by bonding skin edges together, while clinical periodontal dressings, such as PeriAcryl®, are used in periodontal treatment to protect and stabilize gum tissue. These products leverage adhesive technology to support healing and tissue integrity.
Where is Glustich Inc based, and does it operate internationally?
Glustich Inc is based in the United States. While the provided data does not specify international operations, the company’s devices are listed in the FDA’s Unique Device Identifier (UDI) database, indicating compliance with US regulatory requirements. For details on global distribution or regulatory status outside the US, additional research or direct inquiry to the company would be necessary.
Which regulatory registries list Glustich Inc’s medical devices?
Glustich Inc’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and compliance tracking for medical devices under US regulatory oversight. The UDI system assigns a unique product identifier to each device, facilitating transparency in the supply chain and regulatory monitoring.
How are Glustich Inc’s devices classified under FDA regulations?
Glustich Inc’s devices fall under two FDA classification categories: Class I and Class II. Class I devices generally pose minimal risk and are subject to general controls, while Class II devices require additional performance standards due to moderate risk. The classification depends on factors like the device’s intended use and potential health impact, as outlined in the FDA’s regulatory framework.
What is the purpose of the GluStitch® Twist device, and how does it differ from other products in the portfolio?
The GluStitch® Twist is designed specifically for securing skin or soft tissue edges during surgical procedures, distinguishing it from other products like GluSeal® adhesives or PeriAcryl® dressings. While GluSeal® focuses on adhesive wound closure and PeriAcryl® targets periodontal stabilization, GluStitch® Twist combines mechanical fixation with adhesive properties to provide a secure approximation of tissue edges, particularly useful in procedures requiring precise wound alignment.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- glustitch.com
- —
- —
- [email protected]
- Phone
- 1-877-940-2262
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 201637158
Catalogue (25)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| GluSeal®90 | GLUSEAL(ST)C | FDA UDI | Class I | Active |
| PeriAcryl® | P-ACRYL5(C) | FDA UDI | Class II | Active |
| GluSeal® | GLUSEAL(V) | FDA UDI | Class I | Active |
| PeriAcryl® | P-ACRYLU(C) | FDA UDI | Class II | Active |
| GluSeal® | GLUSEAL5(C)HV | FDA UDI | Class I | Active |
| GluSeal® | GLUSEAL5C | FDA UDI | Class I | Active |
| Glustitch Twist | GLTWI05 | FDA UDI | Class II | Unknown |
| PeriAcryl® | P-ACRYLU(V) | FDA UDI | Class II | Active |
| PeriAcryl | P-ACRYLU(V) | FDA UDI | Class II | Unknown |
| PeriAcryl | P-ACRYLU(C) | FDA UDI | Class II | Unknown |
| PeriAcryl® | P-ACRYL9(V) | FDA UDI | Class II | Active |
| Glustitch Twist | GLTWI05C | FDA UDI | Class II | Unknown |
| PeriAcryl® | P-ACRYL2(C) | FDA UDI | Class II | Active |
| GluStitch® Twist | GLTWI05C | FDA UDI | Class II | Active |
| PeriAcryl® | P-ACRYL2(V) | FDA UDI | Class II | Active |
| PeriAcryl® | P-ACRYL5(V) | FDA UDI | Class II | Active |
| GluSeal® | GLUSEAL(C)HV | FDA UDI | Class I | Active |
| PeriAcryl | P-ACRYLU(V)HV | FDA UDI | Class II | Unknown |
| GluSeal® | GLUSEAL5V | FDA UDI | Class I | Active |
| GluSeal® | GLUSEALPT | FDA UDI | Class I | Unknown |
| GluStitch® Twist | GLTWI05 | FDA UDI | Class II | Active |
| PeriAcryl® | P-ACRYL9(V)HV | FDA UDI | Class II | Active |
| GluSeal® | GLUSEAL(C) | FDA UDI | Class I | Active |
| GluSeal®90 | GLUSEAL0.5(ST) | FDA UDI | Class I | Active |
| GluSeal®90 | GLUSEAL(ST) | FDA UDI | Class I | Active |
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