Identity
- Trade Name
- Helistat ® ABSORBABLE COLLAGEN HEMOSTATIC SPONGE FDA UDI
- Generic Name
- Collagen haemostatic agent, non-antimicrobial FDA UDI
- Device Name
- ABSORBABLE COLLAGEN HEMOSTATIC SPONGE, 3IN X 4IN, 5MM THICK FDA UDI
- Model / Reference
- 3410-ZX FDA UDI
- Description
- ABSORBABLE COLLAGEN HEMOSTATIC SPONGE, 3IN X 4IN, 5MM THICK FDA UDI
Identifiers
- Catalog Number
- 3410-ZX FDA UDI
- Primary DI / UDI-DI
- 00381780000207 FDA UDI
- PMA Number
- P850010 FDA UDI
- FDA Product Code
- LMF FDA UDI
- GMDN Term
- Collagen haemostatic agent, non-antimicrobial FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Regulation Number
- 878.4490 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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: Collagen haemostatic agent, non-antimicrobial
Helistat ® ABSORBABLE COLLAGEN HEMOSTATIC SPONGE by Integra Lifesciences Corp. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Collagen haemostatic agent, non-antimicrobial.
- D-Stat® Flowable Hemostat — Vascular Solutions, Inc. · U
- Floseal — Baxter Healthcare Corp · Class III
- Floseal Hemostatic Matrix — Baxter Healthcare Corp · Class III
- Avitene — Davol Inc. · Class III
- FLOSEAL HEMOSTATIC MATRIX — Baxter Healthcare Corp · Class III
- Floseal Special Applicator Tips — Baxter Healthcare Corp · Class III
- Simpurity — SAFE N SIMPLE LLC · Class I
- D-STAT — TELEFLEX INCORPORATED · Class III
Cleared under the same submission
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 5bdb799d-5d44-46d7-8378-a1d5ad5cdd69 37 fields · synced May 30, 2026