Identity
- Trade Name
- Integra® Miltex® HeliTape® FDA UDI
- Generic Name
- General oral wound dressing, animal-derived FDA UDI
- Device Name
- HeliCote® Absorbable Collagen Wound Dressing for Dental Surgery FDA UDI
- Model / Reference
- 62201 FDA UDI
- Description
- HeliCote® Absorbable Collagen Wound Dressing for Dental Surgery FDA UDI
Identifiers
- Catalog Number
- 62-201 FDA UDI
- Primary DI / UDI-DI
- 10381780000297 FDA UDI
- FDA Product Code
- LPG FDA UDI
- GMDN Term
- General oral wound dressing, animal-derived FDA UDI
Classification
- Device Class
- Class III 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: General oral wound dressing, animal-derived
Integra® Miltex® HeliTape® by Integra Lifesciences Corp. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as General oral wound dressing, animal-derived.
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- Symbios® Collagen Tape — Dentsply Implants Manufacturing GmbH · U
- RCT Resorbable Collagen Tape — ACE SURGICAL SUPPLY CO., INC. · Class II
- GIBSON HEALTHCARE — BENCO DENTAL SUPPLY CO. · U
- Curagen collagen wound dressing — MAXIGEN BIOTECH INC. · U
- HealiAid Dental Collagen Wound Dressing — MAXIGEN BIOTECH INC. · U
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 III | Pending data |
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Manufacturer
- Manufacturer
- Integra Lifesciences Corp.
Sources (1)
- FDA UDI e702f0b3-76e8-4b5e-a4a0-996260c068a3 37 fields · synced Jun 1, 2026