DynafitSystem A5080808

GUDID 03701173703657

Superelastic staple 8 x 8 x 8mm sterile

NEOSTEO

Orthopaedic bone staple, non-adjustable, sterile

• Primary Device ID: 03701173703657
• NIH Device Record Key: 31459e92-c6e1-4dab-ae76-fc5c8156e9a5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DynafitSystem
• Version Model Number: A5080808
• Catalog Number: A5080808
• Company DUNS: 261106831
• Company Name: NEOSTEO
• 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: false
• 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 Dimensions

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Operating and Storage Conditions

• Storage Environment Temperature: Between 1 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Device must be stored in a place protected from light and humidity
• Storage Environment Temperature: Between 1 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Device must be stored in a place protected from light and humidity
• Storage Environment Temperature: Between 1 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Device must be stored in a place protected from light and humidity
• Storage Environment Temperature: Between 1 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Device must be stored in a place protected from light and humidity
• Storage Environment Temperature: Between 1 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Device must be stored in a place protected from light and humidity
• Storage Environment Temperature: Between 1 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Device must be stored in a place protected from light and humidity
• Storage Environment Temperature: Between 1 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Device must be stored in a place protected from light and humidity
• Storage Environment Temperature: Between 1 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Device must be stored in a place protected from light and humidity
• Storage Environment Temperature: Between 1 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Device must be stored in a place protected from light and humidity
• Storage Environment Temperature: Between 1 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Device must be stored in a place protected from light and humidity
• Storage Environment Temperature: Between 1 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Device must be stored in a place protected from light and humidity
• Storage Environment Temperature: Between 1 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Device must be stored in a place protected from light and humidity
• Storage Environment Temperature: Between 1 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Device must be stored in a place protected from light and humidity
• Storage Environment Temperature: Between 1 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Device must be stored in a place protected from light and humidity
• Storage Environment Temperature: Between 1 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Device must be stored in a place protected from light and humidity
• Storage Environment Temperature: Between 1 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Device must be stored in a place protected from light and humidity
• Storage Environment Temperature: Between 1 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Device must be stored in a place protected from light and humidity
• Storage Environment Temperature: Between 1 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Device must be stored in a place protected from light and humidity
• Storage Environment Temperature: Between 1 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Device must be stored in a place protected from light and humidity
• Storage Environment Temperature: Between 1 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Device must be stored in a place protected from light and humidity
• Storage Environment Temperature: Between 1 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Device must be stored in a place protected from light and humidity
• Storage Environment Temperature: Between 1 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Device must be stored in a place protected from light and humidity
• Storage Environment Temperature: Between 1 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Device must be stored in a place protected from light and humidity
• Storage Environment Temperature: Between 1 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Device must be stored in a place protected from light and humidity
• Storage Environment Temperature: Between 1 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Device must be stored in a place protected from light and humidity
• Storage Environment Temperature: Between 1 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Device must be stored in a place protected from light and humidity
• Storage Environment Temperature: Between 1 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Device must be stored in a place protected from light and humidity
• Storage Environment Temperature: Between 1 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Device must be stored in a place protected from light and humidity
• Storage Environment Temperature: Between 1 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Device must be stored in a place protected from light and humidity
• Storage Environment Temperature: Between 1 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Device must be stored in a place protected from light and humidity
• Storage Environment Temperature: Between 1 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Device must be stored in a place protected from light and humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	03701173703657 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192447

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: 2020-12-23
• Device Publish Date: 2020-12-15

On-Brand Devices [DynafitSystem]

• 03701173705620: Interphalangeal Joint Fusion Device, Size L, 10°, Sterile
• 03701173705613: Interphalangeal Joint Fusion Device, Size M, 10°, Sterile
• 03701173705606: Interphalangeal Joint Fusion Device, Size S, 10°, Sterile
• 03701173705590: Interphalangeal Joint Fusion Device, Size L, 0°, Sterile
• 03701173705583: Interphalangeal Joint Fusion Device, Size M, 0°, Sterile
• 03701173705576: Interphalangeal Joint Fusion Device, Size S, 0°, Sterile
• 03701173705507: Superelastic staple 25x22x22mm sterile
• 03701173705491: Superelastic staple 20x20x20mm sterile
• 03701173705484: Superelastic staple 20x16x16mm sterile
• 03701173705477: Superelastic staple 18x17x19mm sterile
• 03701173705460: Superelastic staple 18x15x17mm sterile
• 03701173703770: Superelastic staple 18x15x15mm sterile
• 03701173703763: Superelastic staple 18 x 12 x 12mm sterile
• 03701173703756: Superelastic staple 15 x 15 x 15mm sterile
• 03701173703749: Superelastic staple 15 x 12 x 12mm sterile
• 03701173703732: Superelastic staple 12 x 17 x 19mm sterile
• 03701173703725: Superelastic staple 12 x 15 x 17mm sterile
• 03701173703718: Superelastic staple 12 x 13 x 15mm sterile
• 03701173703701: Superelastic staple 12 x 10 x 10mm sterile
• 03701173703695: Superelastic staple 10 x 17 x 19mm sterile
• 03701173703688: Superelastic staple 10 x 15 x 17mm sterile
• 03701173703671: Superelastic staple 10 x 13 x 15mm sterile
• 03701173703664: Superelastic staple 10 x 10 x 10mm sterile
• 03701173703657: Superelastic staple 8 x 8 x 8mm sterile