Pomee - Spencer Stitch 3 1/2" - POMEE CORPORATION

Duns Number:645717646

Device Description: Spencer Stitch 3 1/2"

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More Product Details

Catalog Number

723-3010

Brand Name

Pomee

Version/Model Number

723-3010

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

EGN

Product Code Name

Scissors, Surgical Tissue, Dental

Device Record Status

Public Device Record Key

a3289ff8-85a6-485b-96f9-ac70ffcacfe0

Public Version Date

December 27, 2021

Public Version Number

1

DI Record Publish Date

December 17, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"POMEE CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 616