AccuTip Cover AX9950

GUDID 00897826002086

Individually wrapped

ACCUTOME, INC.

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Primary Device ID00897826002086
NIH Device Record Keyc4117e4f-c21e-4e0e-a99d-c3448e06425c
Commercial Distribution StatusIn Commercial Distribution
Brand NameAccuTip Cover
Version Model NumberAX9950
Catalog NumberAX9950
Company DUNS048792816
Company NameACCUTOME, INC.
Device Count100
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
GS100897826002086 [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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