BioBall™ - BioBall Separating Wedge Size S for use with - Merete GmbH

Duns Number:313267265

Device Description: BioBall Separating Wedge Size S for use with handle HM10005 non-sterile

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More Product Details

Catalog Number

-

Brand Name

BioBall™

Version/Model Number

HM10007

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 13, 2021

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

-

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

11a0e98b-6ed5-448c-89db-39ffe72e11db

Public Version Date

December 14, 2021

Public Version Number

2

DI Record Publish Date

November 01, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MERETE GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 328
2 A medical device with a moderate to high risk that requires special controls. 1327
U Unclassified 13