Identity
- Trade Name
- HEMOBLAST Bellows Laparoscopic Applicator FDA UDI
- Generic Name
- Collagen haemostatic agent, non-antimicrobial FDA UDI
- Device Name
- HEMOBLAST Bellows Laparoscopic Applicator is intended for delivery of HEMOBLAST Bellows hemostatic powder to bleeding surgical sites through a 5mm or larger trocar. FDA UDI
- Model / Reference
- LAP01-US FDA UDI
- Description
- HEMOBLAST Bellows Laparoscopic Applicator is intended for delivery of HEMOBLAST Bellows hemostatic powder to bleeding surgical sites through a 5mm or larger trocar. FDA UDI
Identifiers
- Catalog Number
- LAP01-US FDA UDI
- Primary DI / UDI-DI
- 03760193182668 FDA UDI
- PMA Number
- P170012 FDA UDI
- FDA Product Code
- PMX 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
Yes
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
Dimensions & Sizes
- Size
- Length — 35 Centimeter FDA UDI
Category: Collagen haemostatic agent, non-antimicrobial
HEMOBLAST Bellows Laparoscopic Applicator by Dilon Technologies France — 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
- Helistat® ABSORBABLE COLLAGEN HEMOSTATIC SPONGE — Integra Lifesciences Corp. · 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
Cleared under the same submission
P170012 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 III | Pending data |
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Manufacturer
- Manufacturer
- Dilon Technologies France
Sources (1)
- FDA UDI effcbdef-41a2-4b53-8317-d39f75af687e 38 fields · synced May 30, 2026