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GUDID 06971608311505

Guangzhou Ajax Medical Equipment Co., Ltd.

Steam sterilizer
Primary Device ID06971608311505
NIH Device Record Keyb6f0de91-9699-4a6e-85b9-4000f17d99ab
Commercial Distribution StatusIn Commercial Distribution
Brand NameADS
Version Model NumberACA5
Company DUNS547897476
Company NameGuangzhou Ajax Medical Equipment 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 Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS106971608311505 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FLESterilizer, Steam

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-09-23
Device Publish Date2025-09-15

On-Brand Devices [ADS]

06971608310072AJ19
06971608310065AJ18
06971608310058AJ17
06971608310041AJ16
06971608310034AJ15
06971608310027AJ12
06971608310010AJ11
06971608310003AJ10
06971608311505ACA5

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