UNI-ELBOW 410-0004

GUDID 00886385025971

Radial Head Assy Size 2, Rad

Stryker Trauma SA

Elbow radius prosthesis

• Primary Device ID: 00886385025971
• NIH Device Record Key: 58064952-9288-4994-b949-b9a8a721ca27
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UNI-ELBOW
• Version Model Number: 410-0004
• Catalog Number: 410-0004
• Company DUNS: 481999654
• Company Name: Stryker Trauma SA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00886385025971 [Primary]

FDA Product Code

• JDB: PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2015-09-24

On-Brand Devices [UNI-ELBOW]

• 00886385026473: Radio Capitellum Instrument Tray Lid Uni-Elbow
• 00886385026466: Radio Capitellum Instrument Tray
• 00886385026459: Axis Locator Clamp, Drill Guide
• 00886385026442: Axis Locator Clamp, Upper Arm
• 00886385026435: Axis Locator Clamp, Cup Position Bolt
• 00886385026428: Axis Locator Clamp, Location Cup
• 00886385026411: Axis Locator Clamp, Slot Position Bolt
• 00886385026404: Axis Locator Clamp, L-Bar
• 00886385026374: Resection Guide, Handle
• 00886385026367: Radio Capitellum, Resection Guide, LG
• 00886385026350: Radio Capitellum, Resection Guide, SM
• 00886385026299: Radio Capitellum, Impactor Assembly
• 00886385026268: Radio Capitellum, Broach Right, LG
• 00886385026237: Radio Capitellum, Broach Right, SM
• 00886385026206: Radio Capitellum, Broach Left, LG
• 00886385026176: Radio Capitellum, Broach Left, SM
• 00886385026145: Radio Capitellum, Trial, Right, LG
• 00886385026138: Radio Capitellum, Trial, Right, SM
• 00886385026121: Radio Capitellum, Trial, Left LG
• 00886385026114: Radio Capitellum, Trial, Left SM
• 00886385026091: Radio Capitellum, Template, LG
• 00886385026077: Radio Capitellum, Template, SM
• 00886385026060: Radio Capitellum, Trial, Handle Uni-Elbow
• 00886385026022: Radio Capitellum, Recon Head, Size #4
• 00886385026015: Radio Capitellum, Recon Head, Size #3
• 00886385026008: Radio Capitellum, Recon Head, Size #2
• 00886385025995: Radial Head Assy Size 4, Rad
• 00886385025988: Radial Head Assy Size 3, Rad
• 00886385025971: Radial Head Assy Size 2, Rad
• 00886385025964: Radio Capitellum Small, Right
• 00886385025957: Radio Capitellum Large, Right
• 00886385025940: Radio Capitellum Small, Left
• 00886385025933: Radio Capitellum Large, Left