X3 HUMERAL INSERT
REUNION - 5571-C-3604-A
Device Description
A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of total antibodies to Western equine encephalitis (WEE) virus in a clinical specimen.
Environmental Conditions
No Data Available
Device Sizes
- Length: 4.0 Millimeter
- Diameter: 36.0 Millimeter
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: KWS
Device Name: Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: OR
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: Y
Target Area: N/A
Regulation Number: 888.3660
Third Party Flag: N
Medical Specialty: OR
Code: HSD
Device Name: Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: OR
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: Y
Target Area: N/A
Regulation Number: 888.3690
Third Party Flag: N
Medical Specialty: OR
Device IdentifiersDevice Id: 07613327355321
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A