MasterSL Hip 9035.15.280

GUDID 08033390082983

Broach #8

LIMACORPORATE SPA

Orthopaedic broach

• Primary Device ID: 08033390082983
• NIH Device Record Key: 5d4ae1ca-24a4-4af9-8312-ddbed96f34e3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MasterSL Hip
• Version Model Number: Broach
• Catalog Number: 9035.15.280
• Company DUNS: 432066322
• Company Name: LIMACORPORATE SPA
• 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: false
• 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 Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	08033390082983 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140975

FDA Product Code

• LZO: Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Sterilization

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

[08033390082983]

Moist Heat or Steam Sterilization

[08033390082983]

Moist Heat or Steam Sterilization

[08033390082983]

Moist Heat or Steam Sterilization

[08033390082983]

Moist Heat or Steam Sterilization

[08033390082983]

Moist Heat or Steam Sterilization

[08033390082983]

Moist Heat or Steam Sterilization

[08033390082983]

Moist Heat or Steam Sterilization

[08033390082983]

Moist Heat or Steam Sterilization

[08033390082983]

Moist Heat or Steam Sterilization

[08033390082983]

Moist Heat or Steam Sterilization

[08033390082983]

Moist Heat or Steam Sterilization

[08033390082983]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2021-03-18
• Device Publish Date: 2016-04-12

On-Brand Devices [MasterSL Hip]

• 08033390090735: Lateralized Trial Neck
• 08033390090728: Standard Trial Neck
• 08033390083034: Broach #13
• 08033390083027: Broach #12
• 08033390083010: Broach #11
• 08033390083003: Broach #10
• 08033390082990: Broach #9
• 08033390082983: Broach #8
• 08033390082976: Broach #7
• 08033390082969: Broach #6
• 08033390082952: Broach #5
• 08033390082945: Broach #4
• 08033390082938: Broach #3
• 08033390082921: Broach #2
• 08033390082914: Broach #1
• 08033390197793: Broach #13
• 08033390197786: Broach #12
• 08033390197779: Broach #11
• 08033390197762: Broach #10
• 08033390197755: Broach #9
• 08033390197748: Broach #8
• 08033390197731: Broach #7
• 08033390197724: Broach #6
• 08033390197717: Broach #5
• 08033390197700: Broach #4
• 08033390197694: Broach #3
• 08033390197687: Broach #2
• 08033390197670: Broach #1
• 08033390085304: Woodpecker Straight Adapter
• 08033390084109: MasterSL Hip - Osteotomy Guide
• 08033390083362: MasterSL Hip - Calcar Reamer Plastic Protection
• 08033390083355: MasterSL Hip - Calcar Reamer
• 08033390081658: Reamer
• 08033390083386: Broach Handle