Endoscopic Injection Needle 101087

GUDID 10858015005940

Endoscopic Injection Needle

Carbon Medical Technologies, Inc.

General-purpose endoscopic needle, single-use
Primary Device ID10858015005940
NIH Device Record Keyf30b09bd-cca6-4f1a-9c07-3a63356bc263
Commercial Distribution StatusIn Commercial Distribution
Brand NameEndoscopic Injection Needle
Version Model Number101087
Catalog Number101087
Company DUNS883094039
Company NameCarbon Medical Technologies, Inc.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
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

Device Dimensions

Length140 Centimeter
Length140 Centimeter
Length140 Centimeter
Length140 Centimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100858015005943 [Primary]
GS110858015005940 [Package]
Contains: 00858015005943
Package: Carton [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FBKEndoscopic Injection Needle, Gastroenterology-Urology

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-10-25

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