N/A H48062AN

GUDID 00195278644152

RAB7-D

GE Medical Systems (China) Co.,Ltd.

Extracorporeal ultrasound imaging transducer, hand-held
Primary Device ID00195278644152
NIH Device Record Keyf2bf4118-3cd6-45f5-a796-a57292cdbe05
Commercial Distribution StatusIn Commercial Distribution
Brand NameN/A
Version Model NumberRAB7-D
Catalog NumberH48062AN
Company DUNS654658731
Company NameGE Medical Systems (China) Co.,Ltd.
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 Usetrue
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
GS100195278644152 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-01-17
Device Publish Date2025-01-09

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