Neoligaments TM - Poly-Tape 30mm x 800mm - XIROS LTD

Duns Number:228209805

Device Description: Poly-Tape 30mm x 800mm

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More Product Details

Catalog Number

n/a

Brand Name

Neoligaments TM

Version/Model Number

102-1083

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Conditional

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

JDR

Product Code Name

Staple, Fixation, Bone

Device Record Status

Public Device Record Key

0e66ac5d-8778-4e25-872b-9622a85bff3d

Public Version Date

April 12, 2022

Public Version Number

8

DI Record Publish Date

October 09, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"XIROS LTD" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 11
2 A medical device with a moderate to high risk that requires special controls. 38