OsteoBridge™ IDSF Diaphysis Humeral Spacer Connector - OsteoBridge™ IDSF Diaphysis Humeral Spacer - Merete GmbH

Duns Number:313267265

Device Description: OsteoBridge™ IDSF Diaphysis Humeral Spacer Connector 20 Connection D: 10 TiAl6V4 ELI steri OsteoBridge™ IDSF Diaphysis Humeral Spacer Connector 20 Connection D: 10 TiAl6V4 ELI sterile

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More Product Details

Catalog Number

GB61001S

Brand Name

OsteoBridge™ IDSF Diaphysis Humeral Spacer Connector

Version/Model Number

10

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

K181026

Product Code Details

Product Code

HSB

Product Code Name

Rod, Fixation, Intramedullary And Accessories

Device Record Status

Public Device Record Key

7cb89707-3192-4277-be31-d1c5d0518636

Public Version Date

December 03, 2018

Public Version Number

1

DI Record Publish Date

October 31, 2018

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