AmbiCanner

GUDID 10850018374085

12mil, 12" in length, Latex, Examination Grade, Unlined, Ambidextrous, Fishscale, Beaded Cuff, Blue Color, Size 2X-Large

SUMMIT GLOVE INC.

Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial
Primary Device ID10850018374085
NIH Device Record Key57c70be3-e954-459d-a52b-99f3b72c2731
Commercial Distribution StatusIn Commercial Distribution
Brand NameAmbiCanner
Version Model Number470-11-BL
Company DUNS054386458
Company NameSUMMIT GLOVE INC.
Device Count24
DM Exemptfalse
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(330)868-0066
Emailklynn@summitglove.com
Phone+1(330)868-0066
Emailklynn@summitglove.com
Phone+1(330)868-0066
Emailklynn@summitglove.com
Phone+1(330)868-0066
Emailklynn@summitglove.com
Phone+1(330)868-0066
Emailklynn@summitglove.com
Phone+1(330)868-0066
Emailklynn@summitglove.com
Phone+1(330)868-0066
Emailklynn@summitglove.com
Phone+1(330)868-0066
Emailklynn@summitglove.com
Phone+1(330)868-0066
Emailklynn@summitglove.com
Phone+1(330)868-0066
Emailklynn@summitglove.com
Phone+1(330)868-0066
Emailklynn@summitglove.com
Phone+1(330)868-0066
Emailklynn@summitglove.com
Phone+1(330)868-0066
Emailklynn@summitglove.com
Phone+1(330)868-0066
Emailklynn@summitglove.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100850018374088 [Primary]
GS100850018374095 [Unit of Use]
GS110850018374085 [Package]
Contains: 00850018374088
Package: Box [24 Units]
In Commercial Distribution

FDA Product Code

LYYLatex patient examination glove

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-08-10
Device Publish Date2020-08-01

On-Brand Devices [AmbiCanner]

1085494700598012mil, 12" in length, Latex, Examination Grade, Unlined, Ambidextrous, Fishscale, Beaded Cuff, A
1085494700596612mil, 12" in length, Latex, Examination Grade, Unlined, Ambidextrous, Fishscale, Beaded Cuff, A
1085494700594212mil, 12" in length, Latex, Examination Grade, Unlined, Ambidextrous, Fishscale, Beaded Cuff, A
1085494700592812mil, 12" in length, Latex, Examination Grade, Unlined, Ambidextrous, Fishscale, Beaded Cuff, A
1085494700590412mil, 12" in length, Latex, Examination Grade, Unlined, Ambidextrous, Fishscale, Beaded Cuff, A
1085001999268412mil, 12" in length, Latex, Examination Grade, Unlined, Ambidextrous, Fishscale, Beaded Cuff, B
1085001999266012mil, 12" in length, Latex, Examination Grade, Unlined, Ambidextrous, Fishscale, Beaded Cuff, B
1085001999264612mil, 12" in length, Latex, Examination Grade, Unlined, Ambidextrous, Fishscale, Beaded Cuff, B
1085001999262212mil, 12" in length, Latex, Examination Grade, Unlined, Ambidextrous, Fishscale, Beaded Cuff, B
1085001999260812mil, 12" in length, Latex, Examination Grade, Unlined, Ambidextrous, Fishscale, Beaded Cuff, B
1085001999258512mil, 12" in length, Latex, Examination Grade, Unlined, Ambidextrous, Fishscale, Beaded Cuff, A
1085001999256112mil, 12" in length, Latex, Examination Grade, Unlined, Ambidextrous, Fishscale, Beaded Cuff, A
1085001999254712mil, 12" in length, Latex, Examination Grade, Unlined, Ambidextrous, Fishscale, Beaded Cuff, A
1085001999252312mil, 12" in length, Latex, Examination Grade, Unlined, Ambidextrous, Fishscale, Beaded Cuff, A
1085001999250912mil, 12" in length, Latex, Examination Grade, Unlined, Ambidextrous, Fishscale, Beaded Cuff, A
1085001837408512mil, 12" in length, Latex, Examination Grade, Unlined, Ambidextrous, Fishscale, Beaded Cuff, B
1085001837406112mil, 12" in length, Latex, Examination Grade, Unlined, Ambidextrous, Fishscale, Beaded Cuff, B
1085001837404712mil, 12" in length, Latex, Examination Grade, Unlined, Ambidextrous, Fishscale, Beaded Cuff, B
1085001837402312mil, 12" in length, Latex, Examination Grade, Unlined, Ambidextrous, Fishscale, Beaded Cuff, B
1085001837400912mil, 12" in length, Latex, Examination Grade, Unlined, Ambidextrous, Fishscale, Beaded Cuff, B

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