DEVICE: AutoPlex, VertaPlex (07613154687145)
Device Identifier (DI) Information
AutoPlex, VertaPlex
0605683000
In Commercial Distribution
0605683000
STRYKER CORPORATION
0605683000
In Commercial Distribution
0605683000
STRYKER CORPORATION
System with Needle and Bone Cement
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
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 cement preparation/delivery kit | A collection of sterile surgical instruments, tools, and materials designed to prepare and apply bone cement during an orthopaedic surgical procedure (e.g., hip replacement, arthroplasty, or vertebroplasty). It typically includes items such as forceps, a mallet, cement delivery injectors, delivery tubes, and mixing devices; it may or may not include bone cement. This is a single-use device. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
OAR | Injector, vertebroplasty (does not contain cement) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal |
Storage Environment Humidity: between 30 and 75 Percent (%) Relative Humidity |
Storage Environment Temperature: between 0 and 25 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
Length: 5.0 Inch |
Needle Gauge: 11.0 Gauge |
Device Record Status
3b99174b-6f97-4995-aece-978b60f96810
March 29, 2018
2
September 23, 2016
March 29, 2018
2
September 23, 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 |
---|---|---|---|---|---|
37613154687146 | 2 | 07613154687145 | In Commercial Distribution | pack |
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
[?]
+1(800)253-3210
Inst.Stryker.cs@Stryker.com
Inst.Stryker.cs@Stryker.com