NA - Hangzhou AGS MedTech Co., Ltd.

Duns Number:542984702

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More Product Details

Catalog Number

-

Brand Name

NA

Version/Model Number

AG-5011-2323

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K172727,K172727,K172727

Product Code Details

Product Code

PKL

Product Code Name

Hemostatic Metal Clip For The Gi Tract

Device Record Status

Public Device Record Key

61562863-d398-43cc-bfaa-cebf616bb8f4

Public Version Date

October 17, 2022

Public Version Number

1

DI Record Publish Date

October 09, 2022

Additional Identifiers

Package DI Number

16959664900137

Quantity per Package

10

Contains DI Package

06959664900130

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box

"HANGZHOU AGS MEDTECH CO., LTD." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 2