DEVICE: INSTRUMENT (07613327217001)
Device Identifier (DI) Information
INSTRUMENT
6088-9-810
In Commercial Distribution
6088-9-810
Howmedica Osteonics Corp.
6088-9-810
In Commercial Distribution
6088-9-810
Howmedica Osteonics Corp.
PCA HIP SYSTEM DEPTH GAUGE
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. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
32845 | Surgical depth gauge, reusable |
A surgical instrument designed to measure the depth of a recess, usually to measure the depth of holes being drilled in bone so that the surgeon can determine the length of the bone screw to be used. It may take two forms: 1) a device with a moveable (sliding) centrepiece (a prong), the tip of which is inserted into the recess to read from a scale; 2) a circular disc with a central hole which is clipped to a drill bit so that the device slides up as the drill bit is advanced. This is a reusable device intended to be sterilized prior to use.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KWL | Prosthesis, hip, hemi-, femoral, metal |
MEH | Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate |
MBL | Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous |
KWZ | Prosthesis, hip, constrained, cemented or uncemented, metal/polymer |
LPH | PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED |
HWC | Screw, fixation, bone |
MAY | Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish |
LZO | Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented |
JDI | Prosthesis, hip, semi-constrained, metal/polymer, cemented |
KWY | Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented |
LWJ | Prosthesis, hip, semi-constrained, metal/polymer, uncemented |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Depth: 80.0 Millimeter |
Device Record Status
50f3799b-ae93-40d5-b9ba-e87898db0195
September 27, 2023
4
September 24, 2016
September 27, 2023
4
September 24, 2016
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 |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined