DGH 1006 Corded Pachymeter Probe

GUDID 00857377006209

The DGH1006 is a straight corded probe containing an ultrasonic transducer. This probe is used with DGH ultrasonic pachymeter devices.

DGH TECHNOLOGY INC.

Ophthalmic ultrasound imaging transducer
Primary Device ID00857377006209
NIH Device Record Key14913635-6a39-4c24-9924-1a37673b9dd3
Commercial Distribution StatusIn Commercial Distribution
Brand NameDGH 1006 Corded Pachymeter Probe
Version Model NumberDGH 1006
Company DUNS057188807
Company NameDGH TECHNOLOGY 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 Datefalse
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
GS100857377006209 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ITXTransducer, Ultrasonic, Diagnostic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-07-06
Device Publish Date2016-10-11

Devices Manufactured by DGH TECHNOLOGY INC.

00857377006001 - Pachmate 22018-07-06 The DGH 55B is a Handheld Ultrasonic Pachymeter. It is a hand-held, battery-powered electronic medical device that uses ultrason
00857377006018 - Pachette 42018-07-06 The DGH 555B is a Desktop Ultrasonic Pachymeter. It is a portable, battery-powered electronic medical device that uses ultrasoni
00857377006094 - Scanmate A2018-07-06 The DGH 6000 is a Portable Ultrasonic A-Scan. It is an electronic device that connects to the user's PC via USB connection. It i
00857377006100 - Scanmate B2018-07-06 The DGH 8000 is a Portable Ultrasonic B-Scan. It is an electronic device that connects to the user's PC via USB connection. The
00857377006117 - Scanmate Flex USB Interface2018-07-06 The Scanmate Flex is a multi-purpose computer based ultrasonic diagnostic system for ophthalmic application, intended to both vi
00857377006124 - 20 MHz B-Scan Probe2018-07-06 The DGH1920 is a single-element mechanical sector B-scan probe. This probe connects to the Scanmate Flex USB interface module, w
00857377006131 - 12.5 MHz B-Scan Probe2018-07-06 The DGH1912 is a single-element mechanical sector B-scan probe. This probe connects to the Scanmate Flex USB interface module, w
00857377006148 - UBM Probe2018-07-06 The DGH1500 is a single-element mechanical sector UBM probe. This probe connects to the Scanmate Flex USB interface module, whic

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