CARINA HTR-01-769833

GUDID 00841742100852

CARINA Memory Staple - 15mm x 12mm, SM

HNM TOTAL RECON LLC

Orthopaedic bone staple, non-adjustable, sterile Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable

• Primary Device ID: 00841742100852
• NIH Device Record Key: ba27364b-668c-46cf-8dca-7da5b2968ac4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CARINA
• Version Model Number: HTR-01-769833
• Catalog Number: HTR-01-769833
• Company DUNS: 080024940
• Company Name: HNM TOTAL RECON 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841742100852 [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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-06-09

On-Brand Devices [CARINA ]

• 00841742101002: CARINA Memory Staple, Calcaneal Step - 20mm x 20mm, 12mm Step
• 00841742100999: CARINA Memory Staple, Calcaneal Step - 20mm x 20mm, 9mm Step
• 00841742100982: CARINA Memory Staple, Calcaneal Step - 20mm x 20mm, 6mm Step
• 00841742100975: CARINA Memory Staple, Calcaneal Step - 15mm x 20mm, 12mm Step
• 00841742100968: CARINA Memory Staple, Calcaneal Step - 15mm x 20mm, 9mm Step
• 00841742100951: CARINA Memory Staple, Calcaneal Step - 15mm x 20mm, 6mm Step
• 00841742100944: CARINA Memory Staple - 30mm x 30mm, LG
• 00841742100937: CARINA Memory Staple - 25mm x 22mm, LG
• 00841742100920: CARINA Memory Staple - 20mm x 20mm, LG
• 00841742100913: CARINA Memory Staple - 20mm x 20mm, MD
• 00841742100906: CARINA Memory Staple - 18mm x 18mm x 15mm, MD
• 00841742100890: CARINA Memory Staple - 15mm x 12mm, MD
• 00841742100883: CARINA Memory Staple - 11mm x 19mm x 17mm, SM
• 00841742100876: CARINA Memory Staple - 11mm x 17mm x 15mm, SM
• 00841742100869: CARINA Memory Staple - 11mm x 15mm x 13mm, SM
• 00841742100852: CARINA Memory Staple - 15mm x 12mm, SM
• 00841742100845: CARINA Memory Staple - 13mm x 10mm, SM
• 00841742100838: CARINA Memory Staple - 11mm x 10mm, SM
• 00841742100821: CARINA Memory Staple - 11mm x 8mm, SM
• 00841742100814: CARINA Memory Staple - 9mm x 7mm, SM
• 00841742100807: CARINA Memory Staple - 7mm x 5mm, SM
• 00841742100791: CARINA Memory Staple - 9mm x 7mm, XS
• 00841742100784: CARINA Memory Staple - 7mm x 5mm, XS