KORONA HTR-01-800165

GUDID 00841742100661

KORONA Quad Staple - (L)10mm, 18mmx16mm

HNM TOTAL RECON LLC

Orthopaedic bone staple, non-adjustable, sterile

• Primary Device ID: 00841742100661
• NIH Device Record Key: 37b1ef59-dd25-4892-983c-d78ea9f6cfbf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KORONA
• Version Model Number: HTR-01-800165
• Catalog Number: HTR-01-800165
• 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	00841742100661 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K072298

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 [KORONA ]

• 00841742100777: KORONA Tri Staple - (L)15mm, 18mmx16mm
• 00841742100760: KORONA Tri Staple - (L)12.5mm, 18mmx16mm
• 00841742100753: KORONA Tri Staple - (L)10mm, 18mmx16mm
• 00841742100746: KORONA Tri Staple - (L)15mm,14mmx12mm
• 00841742100739: KORONA Tri Staple - (L)12.5mm,14mmx12mm
• 00841742100722: KORONA Tri Staple - (L)10mm,14mmx12mm
• 00841742100715: KORONA Tri Staple - (L)15mm, 10mmx8mm
• 00841742100708: KORONA Tri Staple - (L)12.5mm, 10mmx8mm
• 00841742100692: KORONA Tri Staple - (L)10mm, 10mmx8mm
• 00841742100685: KORONA Quad Staple - (L)15mm, 18mmx16mm
• 00841742100678: KORONA Quad Staple - (L)12.5mm, 18mmx16mm
• 00841742100661: KORONA Quad Staple - (L)10mm, 18mmx16mm
• 00841742100654: KORONA Quad Staple - (L)15mm, 14mmx12mm
• 00841742100647: KORONA Quad Staple - (L)12.5mm, 14mmx12mm
• 00841742100630: KORONA Quad Staple - (L)10mm, 14mmx12mm
• 00841742100623: KORONA Quad Staple - (L)15mm, 10mmx8mm
• 00841742100616: KORONA Quad Staple - (L)12.5mm, 10mmx8mm
• 00841742100609: KORONA Quad Staple - (L)10mm, 10mmx8mm