Memory Staple

GUDID B56222775WB0

Memory Staple 15 x 15-2 x 1.5mm / SM

WISHBONE MEDICAL, INC.

Orthopaedic bone staple, non-adjustable, sterile

• Primary Device ID: B56222775WB0
• NIH Device Record Key: cc857916-e65d-4f31-baee-25b4300e9ea0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Memory Staple
• Version Model Number: 22775WB
• Company DUNS: 062355158
• Company Name: WISHBONE 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: 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 24 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B56222775WB0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061798

FDA Product Code

• JDR: Staple, Fixation, Bone

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-08-14
• Device Publish Date: 2020-08-06

On-Brand Devices [Memory Staple]

• B56217622WB0: Memory Staple 20 x 20-2 x 3mm / LRG
• B56222775WB0: Memory Staple 15 x 15-2 x 1.5mm / SM
• B56222774WB0: Memory Staple 13 x 15-2 x 1.5mm / SM
• B56219225WB0: Memory Staple 7 x 9-1.2 x 1.2mm / XS
• B56217782WB0: Memory Staple 9 x 9-1.5 x 1.5mm / SM
• B56217781WB0: Memory Staple 7 x 7-1.5 x 1.5mm / SM
• B56217638WB0: Memory Staple 9 x 7-1.2 x 1.2mm / XS
• B56217637WB0: Memory Staple 7 x 5-1.2 x 1.2mm / XS
• B56217636WB0: Memory Staple 11 x 19 x 17-1.5 x 1.5mm / SM
• B56217635WB0: Memory Staple 11 x 17 x 15-1.5 x 1.5mm / SM
• B56217634WB0: Memory Staple 11 x 15 x 13-1.5 x 1.5mm / SM
• B56217633WB0: Memory Staple 15 x 12-1.5 x 1.5mm / SM
• B56217632WB0: Memory Staple 13 x 10-1.5 x 1.5mm / SM
• B56217631WB0: Memory Staple 11 x 10-1.5 x 1.5mm / SM
• B56217630WB0: Memory Staple 11 x 8-1.5 x 1.5mm / SM
• B56217629WB0: Memory Staple 9 x 7-1.5 x 1.5mm / SM
• B56217628WB0: Memory Staple 7 x 5-1.5 x 1.5mm / SM
• B56217627WB0: Memory Staple 20 x 20-2 x 2mm / MED
• B56217626WB0: Memory Staple 18 x 18 x 15-2 x 2mm / MED
• B56217625WB0: Memory Staple 15 x 12-2 x 2mm / MED
• B56217624WB0: Memory Staple 30 x 30-2 x 3mm / LRG
• B56217623WB0: Memory Staple 25 x 22-2 x 3mm / LRG