Simpact - Life Spine, Inc.

Duns Number:183641617

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More Product Details

Catalog Number

-

Brand Name

Simpact

Version/Model Number

152-12-9651

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

Yes

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

K141246

Product Code Details

Product Code

OUR

Product Code Name

Sacroiliac Joint Fixation

Device Record Status

Public Device Record Key

c692be16-980b-4691-a10f-17b1a66e0d34

Public Version Date

December 01, 2021

Public Version Number

1

DI Record Publish Date

November 23, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"LIFE SPINE, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 315
2 A medical device with a moderate to high risk that requires special controls. 9180
U Unclassified 47