BOWTI 172802020

GUDID 10705034015644

BOWTI ANTERIOR BUTTRESS STAPLE 20mm

DEPUY SPINE, LLC

Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 10705034015644
• NIH Device Record Key: a75e1b75-5e63-415e-a6e2-ba2027d3b627
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BOWTI
• Version Model Number: 172802020
• Catalog Number: 172802020
• Company DUNS: 107105876
• Company Name: DEPUY SPINE, LLC
• 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: 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

Customer Support Contacts

• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	10705034015644 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K021039

FDA Product Code

• KWQ: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Sterilization

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

[10705034015644]

Moist Heat or Steam Sterilization

[10705034015644]

Moist Heat or Steam Sterilization

[10705034015644]

Moist Heat or Steam Sterilization

[10705034015644]

Moist Heat or Steam Sterilization

[10705034015644]

Moist Heat or Steam Sterilization

[10705034015644]

Moist Heat or Steam Sterilization

[10705034015644]

Moist Heat or Steam Sterilization

[10705034015644]

Moist Heat or Steam Sterilization

[10705034015644]

Moist Heat or Steam Sterilization

[10705034015644]

Moist Heat or Steam Sterilization

[10705034015644]

Moist Heat or Steam Sterilization

[10705034015644]

Moist Heat or Steam Sterilization

[10705034015644]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2022-11-29
• Device Publish Date: 2015-09-24

On-Brand Devices [BOWTI]

• 10705034185323: BOWTI ANTERIOR BUTTRESS STAPLE SEPARATION BLOCK
• 10705034185286: BOWTI ANTERIOR BUTTRESS STAPLE STAPLE INSERTER
• 10705034185330: BOWTI ANTERIOR BUTTRESS STAPLE CASE AND TRAY
• 10705034185309: BOWTI ANTERIOR BUTTRESS STAPLE STAPLE REMOVER
• 10705034185293: BOWTI ANTERIOR BUTTRESS STAPLE AWL
• 10705034015682: BOWTI ANTERIOR BUTTRESS STAPLE BONE SCREW 5.70 x 30mm
• 10705034015675: BOWTI ANTERIOR BUTTRESS STAPLE BONE SCREW 5.70 x 25mm
• 10705034015668: BOWTI ANTERIOR BUTTRESS STAPLE BONE SCREW 5.70 x 20mm
• 10705034015651: BOWTI ANTERIOR BUTTRESS STAPLE 24mm
• 10705034015644: BOWTI ANTERIOR BUTTRESS STAPLE 20mm