LUPINE ORTHOCORD - LUPINE BR Anchor W/DS ORTHOCORD TCP/PLGA - DEPUY MITEK, LLC

Duns Number:190572854

Device Description: LUPINE BR Anchor W/DS ORTHOCORD TCP/PLGA Absorbable Anchor, with dual size 2 (5 metric) br LUPINE BR Anchor W/DS ORTHOCORD TCP/PLGA Absorbable Anchor, with dual size 2 (5 metric) braided composite suture, violet and blue, 36 Inches (91cm). Size 2 (5 metric) eyelet loop.

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More Product Details

Catalog Number

210712

Brand Name

LUPINE ORTHOCORD

Version/Model Number

210712

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

K070925

Product Code Details

Product Code

GAM

Product Code Name

SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Device Record Status

Public Device Record Key

b3a3f4b6-1a6e-41bd-bbec-f5283ac316ab

Public Version Date

March 21, 2019

Public Version Number

5

DI Record Publish Date

September 01, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DEPUY MITEK, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 560
2 A medical device with a moderate to high risk that requires special controls. 479