NA

GUDID 16959664912055

Hangzhou AGS MedTech Co., Ltd.

Endoscopic electrosurgical handpiece/electrode, monopolar, single-use
Primary Device ID16959664912055
NIH Device Record Keyb41559c8-62e5-4ff8-9c1b-b490fcbfc2f5
Commercial Distribution StatusIn Commercial Distribution
Brand NameNA
Version Model NumberAG-5098-0525
Company DUNS542984702
Company NameHangzhou AGS MedTech 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 Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106959664912058 [Primary]
GS116959664912055 [Package]
Contains: 06959664912058
Package: box [10 Units]
In Commercial Distribution
GS126959664912052 [Package]
Package: carton [100 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KNSUnit, Electrosurgical, Endoscopic (With Or Without Accessories)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-10-17
Device Publish Date2022-10-09

On-Brand Devices [ NA]

16959664912123AG-5099-05
16959664912055AG-5098-0525
16959664900830AG-5063-S2524G
16959664900786AG-5062-N3024G
16959664900779AG-5062-N2524G
16959664900762AG-5062-N2024G
16959664900106AG-5041-2526
16959664900021AG-5041-3526
16959664900014AG-5041-2526

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