Identity
- Trade Name
- SEAL Hemostatic Spray 1.5oz FDA UDI
- Generic Name
- Chitosan haemostatic agent, professional, non-bioabsorbable FDA UDI
- Device Name
- Hemostatic Wound Spray is intended to be used to achieve hemostasis in emergency situations for the temporary control of severe topical bleeding. FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- Hemostatic Wound Spray is intended to be used to achieve hemostasis in emergency situations for the temporary control of severe topical bleeding. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850021825058 FDA UDI
- 510(k) Number
- K210751 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
No
FDA UDI
Over-the-Counter
Yes
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
Radiation Sterilization FDA UDI
Category: Chitosan haemostatic agent, professional, non-bioabsorbable
SEAL Hemostatic Spray 1.5oz by Aerosol And Liquid Packaging — 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
K210751 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 |
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Manufacturer
- Manufacturer
- Aerosol And Liquid Packaging
Sources (1)
- FDA UDI 2c9cc55f-0714-4615-b142-5938b69a7b79 34 fields · synced May 31, 2026