Pachpen- VET 24-5100-V

GUDID 00897826002253

Veterinary

ACCUTOME, INC.

Ultrasound pachymeter Ultrasound pachymeter Ultrasound pachymeter Ultrasound pachymeter Ultrasound pachymeter Ultrasound pachymeter Ultrasound pachymeter Ultrasound pachymeter Ultrasound pachymeter Ultrasound pachymeter Ultrasound pachymeter Ultrasound pachymeter Ultrasound pachymeter Ultrasound pachymeter Ultrasound pachymeter Ultrasound pachymeter
Primary Device ID00897826002253
NIH Device Record Key4346e3dc-acfb-4147-93aa-95297a68e46e
Commercial Distribution StatusIn Commercial Distribution
Brand NamePachpen- VET
Version Model Number24-5100-V
Catalog Number24-5100-V
Company DUNS048792816
Company NameACCUTOME, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100897826002253 [Primary]

FDA Product Code

IYOSystem, Imaging, Pulsed Echo, Ultrasonic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2021-11-29
Device Publish Date2016-10-14

Devices Manufactured by ACCUTOME, INC.

00897826002000 - Accupen2021-11-29
00897826002017 - Pachpen2021-11-29
00897826002024 - A-scan Plus Connect2021-11-29
00897826002031 - B-scan Plus2021-11-29
00897826002055 - Accupach VI2021-11-29
00897826002062 - B-scan Pro2021-11-29
00897826002079 - 4Sight2021-11-29
00897826002086 - AccuTip Cover2021-11-29 Individually wrapped

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