Slap Hammer

GUDID 09348215046255

SIGNATURE ORTHOPAEDICS PTY LTD

Surgical mallet

• Primary Device ID: 09348215046255
• NIH Device Record Key: 56a2322d-3568-47fd-8735-5c47e15a7349
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Slap Hammer
• Version Model Number: 122-16-0313
• Company DUNS: 751993028
• Company Name: SIGNATURE ORTHOPAEDICS PTY LTD
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	09348215046255 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181338

FDA Product Code

• MDM: Instrument, Manual, Surgical, General Use

Sterilization

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

[09348215046255]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-09-18
• Device Publish Date: 2019-02-18

On-Brand Devices [Slap Hammer]

• 09348215046255: 122-16-0313
• 09348215044572: W32-01-0030
• 09348215041410: 122-15-0284
• 09348215058159: 132-23-0030
• 09348215076665: 112-25-0122
• 09348215099145: 02-039-90-3000
• 09348215099138: 122-22-1500