DEVICE: INSTRUMENT (07613327215205)

Device Identifier (DI) Information

INSTRUMENT
2250-32E
In Commercial Distribution
2250-32E
Howmedica Osteonics Corp.
07613327215205
GS1

1
058311945 *Terms of Use
TRIDENT ECCENTRIC INSERT TRIAL
CLOSE

Device Characteristics

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

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
58480 Acetabulum prosthesis trial, prefabricated, reusable
A copy of a final acetabular prosthesis designed to be used for trial reductions during hip arthroplasty to judge the correct size and position of the final acetabular prosthesis to be implanted. It is one of a set, or a set, of graduated sizes, is typically made of metal or polymer material and may be designed in the form of cages, shells, augments, or inserts. This is a reusable device intended to be sterilized prior to use.
Active false
CLOSE

FDA Product Code

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

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No 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
Device Size Text, specify: Degree: 10.0 Degree
Device Size Text, specify: Alpha Code: E
Lumen/Inner Diameter: 32.0 Millimeter
CLOSE

Device Record Status

9036aab8-fe96-408a-8cae-e8a2f51a0f90
March 14, 2022
6
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