DEVICE: INSTRUMENT (07613327208818)

Download: XML | JSON
Print
Device Record History
View all sections | Close all sections

Device Identifier (DI) Information
INSTRUMENT
1100-1113
In Commercial Distribution
1100-1113
Howmedica Osteonics Corp.
07613327208818
GS1

1
058311945 *Terms of Use
OMNIFIT HFX BROACH C11/PF13
CLOSE

Device Characteristics
Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Orthopaedic broach A surgical instrument that is designed as an elongated, tapered and serrated cutting tool intended for shaping and enlarging holes in bone tissue. This is a reusable device.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
LXH ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
CLOSE

FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization
No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status
cf563a90-8ed7-43c7-81c1-cfe3ceaf7026
March 29, 2018
2
September 24, 2016
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
CLOSE