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Hemostatix Thermal Scalpel System Model P8400 Controller
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- HEMOSTATIX THERMAL SCALPEL SYSTEM MODEL P8400 CONTROLLER FDA UDI
- Generic Name
- Haemostatic knife FDA UDI
- Device Name
- HEMOSTATIX THERMAL SCALPEL SYSTEM MODEL P8400 CONTROLLER FDA UDI
- Model / Reference
- 7013-8400 FDA UDI
- Description
- HEMOSTATIX THERMAL SCALPEL SYSTEM MODEL P8400 CONTROLLER FDA UDI
Identifiers
- Catalog Number
- 7013-8400 FDA UDI
- Primary DI / UDI-DI
- 00858736006014 FDA UDI
- 510(k) Number
- K091107 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Haemostatic knife FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Haemostatic knife
Hemostatix Thermal Scalpel System Model P8400 Controller by Hemostatix Medical Technologies Llc — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Haemostatic knife.
- YASARGIL ARACHNOID KNIFE — SONTEC INSTRUMENTS, INC. · Class I
- TREPHINE — KLS-Martin L.P. · Class I
- SHAW SCALPEL — C2DX, INC. · Class II
- SHAW SCALPEL — C2DX, INC. · Class II
- YASARGIL BAYONET ARACHNOID KNIFE — SONTEC INSTRUMENTS, INC. · Class I
- YASARGIL ARACHNOID KNIFE — SONTEC INSTRUMENTS, INC. · Class I
- SHAW SCALPEL — C2DX, INC. · Class II
- SHAW SCALPEL — C2DX, INC. · Class II
Cleared under the same submission
K091107 also covers:
- HEMOSTATIX THERMAL SCALPEL SYSTEM — C2DX, INC.
- SHAW SCALPEL — C2DX, INC.
- SHAW SCALPEL — C2DX, INC.
- HEMOSTATIX THERMAL SCALPEL SYSTEM MODEL 8050 HANDLE - QTY 1 — HEMOSTATIX MEDICAL TECHNOLOGIES LLC
- HEMOSTATIX THERMAL SCALPEL SYSTEM MODEL 8051 HANDLE - QTY 1 — HEMOSTATIX MEDICAL TECHNOLOGIES LLC
- HEMOSTATIX THERMAL SCALPEL SYSTEM MODEL P8400 FOOTSWITCH — HEMOSTATIX MEDICAL TECHNOLOGIES LLC
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 II | Pending data |
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Manufacturer
- Manufacturer
- Hemostatix Medical Technologies Llc
Sources (1)
- FDA UDI ec26f5ad-cd14-4ab2-9e18-a9112db6ba24 36 fields · synced Jun 8, 2026