N/A - INSTRUMENT, MANUAL, SURGICAL, GENERAL USE - GEORGE TIEMANN & CO.

Duns Number:107043630

Device Description: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

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More Product Details

Catalog Number

801260

Brand Name

N/A

Version/Model Number

801260

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

MDM

Product Code Name

INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Device Record Status

Public Device Record Key

00d1250b-6380-4d20-8891-5f8e84525fc8

Public Version Date

December 04, 2020

Public Version Number

2

DI Record Publish Date

September 24, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"GEORGE TIEMANN & CO." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1707