N/A 46.239.002

GUDID 00810633022054

DEPUY SYNTHES HAMMERTOE CCI LARGE KIT W/1.60 K-WIRE/ STERILE

Biomedical Enterprises, Inc.

Orthopaedic bone staple, non-adjustable, sterile

• Primary Device ID: 00810633022054
• NIH Device Record Key: fd3445c4-6b3f-46da-b825-5df9659b3945
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: N/A
• Version Model Number: Large
• Catalog Number: 46.239.002
• Company DUNS: 792619009
• Company Name: Biomedical Enterprises, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: true
• 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

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

Device Dimensions

• Height: 6 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810633022054 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191463

FDA Product Code

• JDR: Staple, 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: 2
• Public Version Date: 2020-05-07
• Device Publish Date: 2020-03-24

On-Brand Devices [N/A]

• 00810633022092: Speed 2.65mm Instrument Kit Comprehensive
• 00810633022085: Speed 2.0mm Instrument Kit Comprehensive
• 00810633022054: DEPUY SYNTHES HAMMERTOE CCI LARGE KIT W/1.60 K-WIRE/ STERILE
• 00810633022047: DEPUY SYNTHES HAMMERTOE CCI STD KIT W/1.25 K-WIRE/ STERILE