OsteoMed - BVF - Bead Mat Pak - OSTEOMED LLC

Duns Number:606417780

Device Description: BVF - Bead Mat Pak

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More Product Details

Catalog Number

390-8507

Brand Name

OsteoMed

Version/Model Number

390-8507

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

-

Product Code Details

Product Code

LXH

Product Code Name

ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Device Record Status

Public Device Record Key

2590689f-0199-4763-8ed0-29ed62a28cb8

Public Version Date

December 29, 2020

Public Version Number

1

DI Record Publish Date

December 21, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"OSTEOMED LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 95
2 A medical device with a moderate to high risk that requires special controls. 7762
U Unclassified 105