NA - HD-D Double Clamp, Approximator without frame, 24 - S & T AG

Duns Number:481542926

Device Description: HD-D Double Clamp, Approximator without frame, 24 mm

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More Product Details

Catalog Number

00326

Brand Name

NA

Version/Model Number

HD-D

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

-

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

-

Product Code Details

Product Code

GDJ

Product Code Name

Clamp, Surgical, General & Plastic Surgery

Device Record Status

Public Device Record Key

3e1558cb-8f8d-44cc-964c-2f989fab3eff

Public Version Date

September 23, 2022

Public Version Number

1

DI Record Publish Date

September 15, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"S & T AG" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 306
2 A medical device with a moderate to high risk that requires special controls. 29