Sgarlato Silastic 70-097-01

GUDID 00819034028948

Universal Broach

FUSION ORTHOPEDICS, LLC

Bone-resection orthopaedic reamer, single-use

• Primary Device ID: 00819034028948
• NIH Device Record Key: b521b80a-41a7-4399-ba1c-aa35a81d9290
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sgarlato Silastic
• Version Model Number: 70-097-01
• Catalog Number: 70-097-01
• Company DUNS: 080307067
• Company Name: FUSION ORTHOPEDICS, LLC
• Device Count: 1
• DM Exempt: true
• 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: true
• 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	00819034028948 [Primary]

FDA Product Code

• KWH: Prosthesis, Toe, Constrained, Polymer

Sterilization

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

[00819034028948]

Moist Heat or Steam Sterilization

[00819034028948]

Moist Heat or Steam Sterilization

[00819034028948]

Moist Heat or Steam Sterilization

[00819034028948]

Moist Heat or Steam Sterilization

[00819034028948]

Moist Heat or Steam Sterilization

[00819034028948]

Moist Heat or Steam Sterilization

[00819034028948]

Moist Heat or Steam Sterilization

[00819034028948]

Moist Heat or Steam Sterilization

[00819034028948]

Moist Heat or Steam Sterilization

[00819034028948]

Moist Heat or Steam Sterilization

[00819034028948]

Moist Heat or Steam Sterilization

[00819034028948]

Moist Heat or Steam Sterilization

[00819034028948]

Moist Heat or Steam Sterilization

[00819034028948]

Moist Heat or Steam Sterilization

[00819034028948]

Moist Heat or Steam Sterilization

[00819034028948]

Moist Heat or Steam Sterilization

[00819034028948]

Moist Heat or Steam Sterilization

[00819034028948]

Moist Heat or Steam Sterilization

[00819034028948]

Moist Heat or Steam Sterilization

[00819034028948]

Moist Heat or Steam Sterilization

[00819034028948]

Moist Heat or Steam Sterilization

[00819034028948]

Moist Heat or Steam Sterilization

[00819034028948]

Moist Heat or Steam Sterilization

[00819034028948]

Moist Heat or Steam Sterilization

[00819034028948]

Moist Heat or Steam Sterilization

[00819034028948]

Moist Heat or Steam Sterilization

[00819034028948]

Moist Heat or Steam Sterilization

[00819034028948]

Moist Heat or Steam Sterilization

[00819034028948]

Moist Heat or Steam Sterilization

[00819034028948]

Moist Heat or Steam Sterilization

[00819034028948]

Moist Heat or Steam Sterilization

[00819034028948]

Moist Heat or Steam Sterilization

[00819034028948]

Moist Heat or Steam Sterilization

[00819034028948]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-09-13
• Device Publish Date: 2020-11-19

On-Brand Devices [Sgarlato Silastic]

• 00819034029242: SHIP Long/Shaw Drill Stiff
• 00819034029235: SHIP Long/Shaw Drill Regular
• 00819034029228: SHIP Long/Shaw Drill Flexible
• 00819034028900: SHIP Long/Shaw Drill Regular
• 00819034028894: SHIP Long/Shaw Drill Flexible
• 00819034028887: SHIP Long/Shaw Drill Stiff
• 00819034028795: SHIP Short Sizer Medium
• 00819034028788: GAIT Football Burr
• 00819034028627: Shaw Rod Sizer Stiff
• 00819034028610: Shaw Rod Sizer Regular
• 00819034028603: Shaw Rod Sizer Flexible
• 00819034028597: Shaw Rod Sizer Kit
• 00819034028566: SHIP Long Sizer Regular
• 00819034028559: SHIP Long Sizer Kit
• 00819034028511: Shaw Rod Implant Stiff
• 00819034028504: Shaw Rod Implant Regular
• 00819034028498: Shaw Rod Implant Flexible
• 00819034028481: SHIP Short Implant Medium
• 00819034028306: GAIT Grommets Large
• 00819034027026: Gait Handle Reusable
• 00819034026999: GAIT Grommets Medium
• 00819034026982: GAIT Grommets
• 00819034026937: GAIT Sizer Large
• 00819034026920: GAIT Sizer Medium
• 00819034026913: GAIT Sizer Small
• 00819034028856: GAIT Pick and Press Inserter
• 00819034028849: GAIT Football Burr
• 00819034028542: SHIP Long Implant Stiff
• 00819034028535: SHIP Long Implant Flexible
• 00819034028528: SHIP Long Implant Regular
• 00819034028474: SHIP Short Implant Small
• 00819034026975: GAIT Implant System Large
• 00819034026968: GAIT Implant System Medium
• 00819034026951: GAIT Implant System Small
• 00840124506169: Shaw Rod Sizer Stiff
• 00840124506152: Shaw Rod Sizer Regular
• 00840124506145: Shaw Rod Sizer Flexible
• 00840124506138: SHIP Long Sizer Flexible
• 00840124508989: SHIP Broach Short
• 00840124507456: SHIP Broach Short
• 00819034029211: GAIT Pick and Press Inserter
• 00819034029198: GAIT Broach (Diamond) Proximal
• 00819034029181: GAIT Broach (Diamond) Distal
• 00819034028948: Universal Broach
• 00819034028931: SHIP Short Reamer Medium
• 00819034028924: SHIP Short Reamer Small
• 00819034028832: GAIT Broach (Diamond) Proximal
• 00819034028825: GAIT Broach (Diamond) Distal
• 00819034028818: GAIT Broach (Lined) Proximal
• 00819034028801: GAIT Broach (Lined) Distal