Handle

GUDID 08720254007847

Spierings Orthopaedics B.V.

Manual bone mill

• Primary Device ID: 08720254007847
• NIH Device Record Key: 10173af0-0a9f-436b-86b3-1b21ad6489d2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Handle
• Version Model Number: SMT-SBM-9801-06
• Company DUNS: 407288690
• Company Name: Spierings Orthopaedics B.V.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08720254007847 [Primary]

FDA Product Code

• LYS: Bone Mill

Sterilization

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

[08720254007847]

Moist Heat or Steam Sterilization

[08720254007847]

Moist Heat or Steam Sterilization

[08720254007847]

Moist Heat or Steam Sterilization

[08720254007847]

Moist Heat or Steam Sterilization

[08720254007847]

Moist Heat or Steam Sterilization

[08720254007847]

Moist Heat or Steam Sterilization

[08720254007847]

Moist Heat or Steam Sterilization

[08720254007847]

Moist Heat or Steam Sterilization

[08720254007847]

Moist Heat or Steam Sterilization

[08720254007847]

Moist Heat or Steam Sterilization

[08720254007847]

Moist Heat or Steam Sterilization

[08720254007847]

Moist Heat or Steam Sterilization

[08720254007847]

Moist Heat or Steam Sterilization

[08720254007847]

Moist Heat or Steam Sterilization

[08720254007847]

Moist Heat or Steam Sterilization

[08720254007847]

Moist Heat or Steam Sterilization

[08720254007847]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-28
• Device Publish Date: 2023-06-20

Devices Manufactured by Spierings Orthopaedics B.V.

• 08720828234181 - KINCISE™ System Acetabular Cup Extraction Case Standard Set: 2024-04-03
• 08720828234198 - KINCISE™ System Acetabular Cup Extraction Case Outlier Set: 2024-04-03
• 08720254007472 - KINCISE™ System Acetabular Cup Extraction Finisher Blade 44mm: 2024-03-28
• 08720254007489 - KINCISE™ System Acetabular Cup Extraction Finisher Blade 46mm: 2024-03-28
• 08720254007496 - KINCISE™ System Acetabular Cup Extraction Finisher Blade 48mm: 2024-03-28
• 08720254007502 - KINCISE™ System Acetabular Cup Extraction Finisher Blade 50mm: 2024-03-28
• 08720254007519 - KINCISE™ System Acetabular Cup Extraction Finisher Blade 52mm: 2024-03-28
• 08720254007526 - KINCISE™ System Acetabular Cup Extraction Finisher Blade 54mm: 2024-03-28