HEMOSTATIX THERMAL SCALPEL SYSTEM

GUDID 00850007350208

MODEL P8400 CONSOLE - QTY 1

C2DX, INC.

Haemostatic knife
Primary Device ID00850007350208
NIH Device Record Keyd864d965-1bd6-4fda-9600-5553724590fa
Commercial Distribution StatusIn Commercial Distribution
Brand NameHEMOSTATIX THERMAL SCALPEL SYSTEM
Version Model Number7013-8400
Company DUNS116981210
Company NameC2DX, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone888-902-2239
EmailSALES@C2DX.COM
Phone888-902-2239
EmailSALES@C2DX.COM
Phone888-902-2239
EmailSALES@C2DX.COM
Phone888-902-2239
EmailSALES@C2DX.COM
Phone888-902-2239
EmailSALES@C2DX.COM
Phone888-902-2239
EmailSALES@C2DX.COM
Phone888-902-2239
EmailSALES@C2DX.COM
Phone888-902-2239
EmailSALES@C2DX.COM
Phone888-902-2239
EmailSALES@C2DX.COM
Phone888-902-2239
EmailSALES@C2DX.COM
Phone888-902-2239
EmailSALES@C2DX.COM
Phone888-902-2239
EmailSALES@C2DX.COM
Phone888-902-2239
EmailSALES@C2DX.COM
Phone888-902-2239
EmailSALES@C2DX.COM
Phone888-902-2239
EmailSALES@C2DX.COM
Phone888-902-2239
EmailSALES@C2DX.COM
Phone888-902-2239
EmailSALES@C2DX.COM

Device Identifiers

Device Issuing AgencyDevice ID
GS100850007350208 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEIElectrosurgical, Cutting & Coagulation & Accessories

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-12-28
Device Publish Date2023-12-20

Devices Manufactured by C2DX, INC.

00850007350208 - HEMOSTATIX THERMAL SCALPEL SYSTEM2023-12-28MODEL P8400 CONSOLE - QTY 1
00850007350208 - HEMOSTATIX THERMAL SCALPEL SYSTEM2023-12-28 MODEL P8400 CONSOLE - QTY 1
00850007350222 - SHAW SCALPEL2023-12-28 FOOTSWITCH FOR P8400 CONSOLE
10850007350236 - SHAW SCALPEL2023-12-28 MODEL 8050 HANDLE - QTY 1
10850007350250 - SHAW SCALPEL2023-12-28 MODEL 9050 HANDLE - QTY 1
00850007350260 - SHAW SCALPEL2023-12-28 MODEL 5712 BLADE - QTY 10
00850007350215 - SHAW SCALPEL2023-12-28 MODEL 5710 BLADE - QTY 24
00850007350253 - SHAW SCALPEL2023-12-28 MODEL 9050 HANDLE - QTY 6
00850007350277 - SHAW SCALPEL2023-12-28 MODEL 5715 BLADE - QTY 24

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