Pachpen 24-5100

GUDID 00897826002017

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 ID00897826002017
NIH Device Record Keyca8db09f-d072-4385-9efb-086526778535
Commercial Distribution StatusIn Commercial Distribution
Brand NamePachpen
Version Model Number24-5100
Catalog Number24-5100
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
GS100897826002017 [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 Date2016-09-13

Devices Manufactured by ACCUTOME, INC.

00897826002000 - Accupen2021-11-29
00897826002017 - Pachpen2021-11-29
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

Trademark Results [Pachpen]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PACHPEN
PACHPEN
76620483 3088174 Live/Registered
ACCUTOME ULTRASOUND, INC.
2004-11-15

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.