mytaMed - Olsen-Hegar Needle Holder, 11.5cm, Serrated TC - Mytamed, Inc.

Duns Number:015903922

Device Description: Olsen-Hegar Needle Holder, 11.5cm, Serrated TC Jaws

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More Product Details

Catalog Number

BA6062

Brand Name

mytaMed

Version/Model Number

BA6062

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)

-

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

FHQ

Product Code Name

Holder, Needle, Gastroenterologic

Device Record Status

Public Device Record Key

c56774ef-ec88-4cd2-8e6f-be1bb5f54982

Public Version Date

October 06, 2021

Public Version Number

1

DI Record Publish Date

September 28, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MYTAMED, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 861
2 A medical device with a moderate to high risk that requires special controls. 21