Identity
- Trade Name
- InnoSEAL Hemostatic Pad FDA UDI
- Generic Name
- Chitosan haemostatic agent, professional, non-bioabsorbable FDA UDI
- Device Name
- InnoSEAL Hemostatic Pad is a hydrophilic, lyophilized sponge pad for local management of bleeding wound made of proprietary formulation of chitosan and catechol conjugated chitosan which are biocompatible. InnoSEAL Hemostatic Pad is applied topically as an adjunct to manual compression. InnoSEAL Hemostatic Pad is a single use device individually packaged by PET mold and Aluminum lid and sterilized with gamma irradiation. FDA UDI
- Model / Reference
- IS-H-01-20 FDA UDI
- Description
- InnoSEAL Hemostatic Pad is a hydrophilic, lyophilized sponge pad for local management of bleeding wound made of proprietary formulation of chitosan and catechol conjugated chitosan which are biocompatible. InnoSEAL Hemostatic Pad is applied topically as an adjunct to manual compression. InnoSEAL Hemostatic Pad is a single use device individually packaged by PET mold and Aluminum lid and sterilized with gamma irradiation. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800030700138 FDA UDI
- 510(k) Number
- K161013 FDA UDI
- FDA Product Code
- FRO FDA UDI
- GMDN Term
- Chitosan haemostatic agent, professional, non-bioabsorbable FDA UDI
Classification
- Device Class
- U 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: Chitosan haemostatic agent, professional, non-bioabsorbable
InnoSEAL Hemostatic Pad by SCL Science Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Chitosan haemostatic agent, professional, non-bioabsorbable.
- Celox Rapid Z-Fold Gauze — Medtrade Products , Ltd. · U
- HemCon ChitoGauze XR2 Pro, 3in x 4yd — Tricol Biomedical, INC. · U
- QUIKCLOT — TELEFLEX INCORPORATED · U
- CELOX Gauze — Medtrade Products , Ltd. · U
- HemCon® OneStop™ Bandage, 2in x 2in — Tricol Biomedical, INC. · U
- PosiSep X2 0.8" x 2.3" — Hemostasis, LLC · Class I
- CELOX Vascular — Medtrade Products , Ltd. · U
- Axiostat Patch — Advamedica, Inc. · U
Cleared under the same submission
K161013 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 U | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- SCL Science Inc.
Sources (1)
- FDA UDI 8aefbff1-a924-43d4-b6c3-0b8b6a4d4c9e 36 fields · synced May 30, 2026