SNAP-OFF 117116SND

GUDID 10381780047803

The titanium alloy SNAP-OFF screws are dedicated for the fixation of the HALLU-C, HALLU-S and B-BOP plates. They are available in different diameters and sizes. They exist in different colors for size identification. The unthreaded part provides the system with the mechanism for the bone to slide along this unthreaded body. The design of the thread allows the snap-off screw to be self tapping so that no pre-tap is required when implanting the device .The distal end of the snap-off screw has a smooth tip to protect tissues.

NEWDEAL

Orthopaedic bone screw, non-bioabsorbable, sterile

• Primary Device ID: 10381780047803
• NIH Device Record Key: 93d0a983-abc3-4fc1-aef5-9bfd02cbc8f5
• Commercial Distribution Discontinuation: 2027-12-31
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SNAP-OFF
• Version Model Number: 117116SND
• Catalog Number: 117116SND
• Company DUNS: 536935331
• Company Name: NEWDEAL
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com

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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place.

Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780047803 [Primary]
HIBCC	M248117116SND1 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K052152

FDA Product Code

• HRS: PLATE, FIXATION, BONE

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2023-02-09
• Device Publish Date: 2017-10-09

On-Brand Devices [SNAP-OFF]

• 10381780047865: The titanium alloy SNAP-OFF screws are dedicated for the fixation of the HALLU-C, HALLU-S and B-
• 10381780047858: The titanium alloy SNAP-OFF screws are dedicated for the fixation of the HALLU-C, HALLU-S and B-
• 10381780047841: The titanium alloy SNAP-OFF screws are dedicated for the fixation of the HALLU-C, HALLU-S and B-
• 10381780047834: The titanium alloy SNAP-OFF screws are dedicated for the fixation of the HALLU-C, HALLU-S and B-
• 10381780047827: The titanium alloy SNAP-OFF screws are dedicated for the fixation of the HALLU-C and HALLU-S pla
• 10381780047810: The titanium alloy SNAP-OFF screws are dedicated for the fixation of the HALLU-C and HALLU-S pla
• 10381780047803: The titanium alloy SNAP-OFF screws are dedicated for the fixation of the HALLU-C, HALLU-S and B-
• 10381780047797: The titanium alloy SNAP-OFF screws are dedicated for the fixation of the HALLU-C and HALLU-S pla
• 10381780047780: The titanium alloy SNAP-OFF screws are dedicated for the fixation of the HALLU-C, HALLU-S and B-
• 10381780047773: The titanium alloy SNAP-OFF screws are dedicated for the fixation of the HALLU-C and HALLU-S pla
• 10381780047766: The titanium alloy SNAP-OFF screws are dedicated for the fixation of the HALLU-C and HALLU-S pla
• M248117112ND1: The titanium alloy SNAP-OFF screws are dedicated for the fixation of the HALLU-C and HALLU-S pla
• 10381780047742: The titanium alloy SNAP-OFF screws are dedicated for the fixation of the HALLU-C and HALLU-S pla
• M248117110ND1: The titanium alloy SNAP-OFF screws are dedicated for the fixation of the HALLU-C and HALLU-S pla
• 10381780047728: The titanium alloy SNAP-OFF screws are dedicated for the fixation of the HALLU-C and HALLU-S pla
• 10381780047711: The titanium alloy SNAP-OFF screws are dedicated for the fixation of the HALLU-C and HALLU-S pla
• 10381780047704: The titanium alloy SNAP-OFF screws are dedicated for the fixation of the HALLU-C and HALLU-S pla
• M248117032ND1: The titanium alloy SNAP-OFF screws are dedicated for the fixation of the HALLU-C and HALLU-S pla
• 10381780047681: The titanium alloy SNAP-OFF screws are dedicated for the fixation of the HALLU-C and HALLU-S pla
• M248117030ND1: The titanium alloy SNAP-OFF screws are dedicated for the fixation of the HALLU-C and HALLU-S pla
• 10381780047667: The titanium alloy SNAP-OFF screws are dedicated for the fixation of the HALLU-C and HALLU-S pla
• 10381780047650: The titanium alloy SNAP-OFF screws are dedicated for the fixation of the HALLU-C and HALLU-S pla
• 10381780047643: The titanium alloy SNAP-OFF screws are dedicated for the fixation of the HALLU-C and HALLU-S pla
• 10381780047636: The titanium alloy SNAP-OFF screws are dedicated for the fixation of the HALLU-C and HALLU-S pla
• 10381780047629: The titanium alloy SNAP-OFF screws are dedicated for the fixation of the HALLU-C and HALLU-S pla
• 10381780047612: The titanium alloy SNAP-OFF screws are dedicated for the fixation of the HALLU-C and HALLU-S pla
• 10381780047605: The titanium alloy SNAP-OFF screws are dedicated for the fixation of the HALLU-C and HALLU-S pla
• M248117022ND1: The titanium alloy SNAP-OFF screws are dedicated for the fixation of the HALLU-C and HALLU-S pla
• 10381780047582: The titanium alloy SNAP-OFF screws are dedicated for the fixation of the HALLU-C and HALLU-S pla
• M248117020ND1: The titanium alloy SNAP-OFF screws are dedicated for the fixation of the HALLU-C and HALLU-S pla
• 10381780047568: The titanium alloy SNAP-OFF screws are dedicated for the fixation of the HALLU-C and HALLU-S pla
• 10381780047551: The titanium alloy SNAP-OFF screws are dedicated for the fixation of the HALLU-C and HALLU-S pla
• 10381780047544: The titanium alloy SNAP-OFF screws are dedicated for the fixation of the HALLU-C and HALLU-S pla
• 10381780047537: The titanium alloy SNAP-OFF screws are dedicated for the fixation of the HALLU-C and HALLU-S pla
• 10381780047520: The titanium alloy SNAP-OFF screws are dedicated for the fixation of the HALLU-C and HALLU-S pla
• M248117014ND1: The titanium alloy SNAP-OFF screws are dedicated for the fixation of the HALLU-C and HALLU-S pla
• 10381780047506: The titanium alloy SNAP-OFF screws are dedicated for the fixation of the HALLU-C and HALLU-S pla
• M248117012ND1: The titanium alloy SNAP-OFF screws are dedicated for the fixation of the HALLU-C and HALLU-S pla
• 10381780047483: The titanium alloy SNAP-OFF screws are dedicated for the fixation of the HALLU-C and HALLU-S pla
• M248117010ND1: The titanium alloy SNAP-OFF screws are dedicated for the fixation of the HALLU-C and HALLU-S pla