Injection Procedure Kit 101088

GUDID 00858015005950

Injection Procedure Kit including Three-Way Stopcock, Fluid Dispensing Connector and Auxiliary Reservoir Syringe

Carbon Medical Technologies, Inc.

General/plastic surgical procedure kit, non-medicated, single-use
Primary Device ID00858015005950
NIH Device Record Key10895820-c326-4ac9-909a-27ac7d79e7b4
Commercial Distribution StatusIn Commercial Distribution
Brand NameInjection Procedure Kit
Version Model Number101088
Catalog Number101088
Company DUNS883094039
Company NameCarbon Medical Technologies, Inc.
Device Count1
DM Exempttrue
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone8882070262
Emailinfo@carbonmed.com
Phone8882070262
Emailinfo@carbonmed.com
Phone8882070262
Emailinfo@carbonmed.com
Phone8882070262
Emailinfo@carbonmed.com
Phone8882070262
Emailinfo@carbonmed.com
Phone8882070262
Emailinfo@carbonmed.com
Phone8882070262
Emailinfo@carbonmed.com
Phone8882070262
Emailinfo@carbonmed.com
Phone8882070262
Emailinfo@carbonmed.com
Phone8882070262
Emailinfo@carbonmed.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100858015005950 [Primary]

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-05-08
Device Publish Date2017-12-04

Devices Manufactured by Carbon Medical Technologies, Inc.

10850002461340 - BiomarC®2024-07-31 FIDUCIAL MARKER SYSTEM, EX
10850002461357 - Carbon Bright ®2024-07-31 CARBON FIDUCIAL MARKER - DISTAL DELIVERY
10850002461302 - BIOMARC ® EX2022-02-15 FIDUCIAL MARKER SYSTEM
00850002461091 - BiomarC® Restore2021-12-24 LOW DENSITY FIDUCIAL MARKER
00850002461107 - BIOMARC® RESTORE 2021-12-24 LOW DENSITY FIDUCIAL MARKER
00850002461152 - BIOMARC ® RESTORE2021-12-24 MIDDLE DENSITY FIDUCIAL MARKER
00850002461169 - BIOMARC ® RESTORE2021-12-24 HIGH DENSITY FIDUCIAL MARKER
00850002461176 - BIOMARC ® RESTORE2021-12-24 MIDDLE DENSITY FIDUCIAL MARKER

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.