DEVICE: INSTRUMENT (07613327209853)

Device Identifier (DI) Information

INSTRUMENT
1119-2100
In Commercial Distribution
1119-2100
Howmedica Osteonics Corp.
07613327209853
GS1

1
058311945 *Terms of Use
FEMORAL STEM IMPACTOR/EXTRACTOR- THREADED DRIVER
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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 impactor A metal and/or plastic hand-held manual surgical instrument designed to position an implant into the body. Its mode of application is by transmission of an impact force to drive the implant into its final position in the body. The proximal end is a handle usually designed to absorb the impact from a surgical hammer or mallet. The distal end is usually shaped to conform to the implant shape, which could be flat or anatomically curved, or shaped like a chisel handle to facilitate the positioning. This is a reusable device.
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FDA Product Code

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Product Code Product Code Name
MAY Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish
JDI Prosthesis, hip, semi-constrained, metal/polymer, cemented
MBL Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous
LWJ Prosthesis, hip, semi-constrained, metal/polymer, uncemented
KWY Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
MEH Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate
LPH PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
HWC Screw, fixation, bone
KWZ Prosthesis, hip, constrained, cemented or uncemented, metal/polymer
KWL Prosthesis, hip, hemi-, femoral, metal
LZO Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
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FDA Premarket Submission

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

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

80dbd61f-cb88-4aec-90ee-7aa009401ee5
March 29, 2018
2
September 24, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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