AccuTip Cover AX11932

GUDID 00897826002093

Individually wrapped

ACCUTOME, INC.

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Primary Device ID00897826002093
NIH Device Record Keyc05869cf-5354-484e-a7dd-d4cd6c53b21d
Commercial Distribution StatusIn Commercial Distribution
Brand NameAccuTip Cover
Version Model NumberAX11932
Catalog NumberAX11932
Company DUNS048792816
Company NameACCUTOME, INC.
Device Count300
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100897826002093 [Primary]
GS100897826002130 [Unit of Use]

FDA Product Code

HKYTonometer, Manual

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2021-11-29
Device Publish Date2016-09-13

On-Brand Devices [AccuTip Cover ]

00897826002116Bulk, non-sleeved
00897826002109Sleeved
00897826002093Individually wrapped
00897826002086Individually wrapped

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