DEVICE: INSTRUMENT (07613327186864)

Device Identifier (DI) Information

INSTRUMENT
4849-8-001
In Commercial Distribution
4849-8-001
Howmedica Osteonics Corp.
07613327186864
GS1

1
058311945 *Terms of Use
ABG II EXTRACTOR FOR FEMORAL STEM V40 WITH PLASTIC PROTECTION
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 implant inserter/extractor A hand-held manual surgical instrument designed to insert or extract an implantable orthopaedic device (e.g., a bone nail, spiral blade, or bone fixation plate) into or out of the body. It is a robust instrument that has a mechanism (e.g., a sturdy hook that slots into one of the nail's locking screw holes, or a tapered/straight thread that locks into the inner material/thread of the implant's construct, or a clamp that will attach and/or lock to an exposed part of the implant). It is typically made of stainless steel/synthetic material and the surgeon can make strikes on the proximal end with a surgical hammer or mallet to insert/extract the implant. 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

bf4f6b9a-c505-4836-9b7d-f5a31d0563e3
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