GLOBAL UNITE™ Short Stem Instrumentation

GUDID 00817766026423

SHORT HUMERAL CASE

SYMMETRY MEDICAL INC.

Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable

• Primary Device ID: 00817766026423
• NIH Device Record Key: 0534fdcf-a16b-4628-a639-20c2b9a85fd2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GLOBAL UNITE™ Short Stem Instrumentation
• Version Model Number: 223600211
• Company DUNS: 079881212
• Company Name: SYMMETRY MEDICAL INC.
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• 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	00817766026423 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K012105

FDA Product Code

• KCT: Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

Sterilization

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

[00817766026423]

Moist Heat or Steam Sterilization

[00817766026423]

Moist Heat or Steam Sterilization

[00817766026423]

Moist Heat or Steam Sterilization

[00817766026423]

Moist Heat or Steam Sterilization

[00817766026423]

Moist Heat or Steam Sterilization

[00817766026423]

Moist Heat or Steam Sterilization

[00817766026423]

Moist Heat or Steam Sterilization

[00817766026423]

Moist Heat or Steam Sterilization

[00817766026423]

Moist Heat or Steam Sterilization

[00817766026423]

Moist Heat or Steam Sterilization

[00817766026423]

Moist Heat or Steam Sterilization

[00817766026423]

Moist Heat or Steam Sterilization

[00817766026423]

Moist Heat or Steam Sterilization

[00817766026423]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-04-04
• Device Publish Date: 2021-09-01

On-Brand Devices [GLOBAL UNITE™ Short Stem Instrumentation]

• 00817766026423: SHORT HUMERAL CASE
• 00847538018776: SHORT BULLET TIP REAMER 16MM
• 00847538018769: SHORT BULLET TIP REAMER 14MM
• 00847538018745: SHORT BULLET TIP REAMER 12MM
• 00847538018738: SHORT BULLET TIP REAMER 10MM
• 00847538018721: SHORT BULLET TIP REAMER 8MM