RULTRACT - Rultract Re-Sternotomy Assist, Hook - PEMCO INC

Duns Number:004217071

Device Description: Rultract Re-Sternotomy Assist, Hook

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More Product Details

Catalog Number

4100-52RDH

Brand Name

RULTRACT

Version/Model Number

4100-52RDH

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

DWS

Product Code Name

Instruments, Surgical, Cardiovascular

Device Record Status

Public Device Record Key

35be99fa-6517-40ca-9747-711b1e70ec33

Public Version Date

December 14, 2021

Public Version Number

1

DI Record Publish Date

December 06, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PEMCO INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 58
2 A medical device with a moderate to high risk that requires special controls. 160