VOLANS HTR-01-680967

GUDID 00841742100432

VOLANS Lesser MPJ Hemi - 8.75mm

HNM TOTAL RECON LLC

Orthopaedic bone pin, non-bioabsorbable

• Primary Device ID: 00841742100432
• NIH Device Record Key: 4adba00b-6c71-46be-8e54-60d73ab53150
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VOLANS
• Version Model Number: HTR-01-680967
• Catalog Number: HTR-01-680967
• Company DUNS: 080024940
• Company Name: HNM TOTAL RECON LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• 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	00841742100432 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041595

FDA Product Code

• KWD: Prosthesis, Toe, Hemi-, Phalangeal

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: 2016-09-23

On-Brand Devices [VOLANS ]

• 00841742100593: VOLANS Lesser MPJ Hemi, Cannulated - 14mm
• 00841742100586: VOLANS Lesser MPJ Hemi, Cannulated - 13.25mm
• 00841742100579: VOLANS Lesser MPJ Hemi, Cannulated - 12.5mm
• 00841742100562: VOLANS Lesser MPJ Hemi, Cannulated - 11.75mm
• 00841742100555: VOLANS Lesser MPJ Hemi, Cannulated - 11mm
• 00841742100548: VOLANS Lesser MPJ Hemi, Cannulated - 10.25mm
• 00841742100531: VOLANS Lesser MPJ Hemi, Cannulated - 9.5mm
• 00841742100524: VOLANS Lesser MPJ Hemi, Cannulated - 8.75mm
• 00841742100517: VOLANS Lesser MPJ Hemi, Cannulated - 8mm
• 00841742100500: VOLANS Lesser MPJ Hemi - 14mm
• 00841742100494: VOLANS Lesser MPJ Hemi - 13.25mm
• 00841742100487: VOLANS Lesser MPJ Hemi - 12.5mm
• 00841742100470: VOLANS Lesser MPJ Hemi - 11.75mm
• 00841742100463: VOLANS Lesser MPJ Hemi - 11mm
• 00841742100456: VOLANS Lesser MPJ Hemi - 10.25mm
• 00841742100449: VOLANS Lesser MPJ Hemi - 9.5mm
• 00841742100432: VOLANS Lesser MPJ Hemi - 8.75mm
• 00841742100425: VOLANS Lesser MPJ Hemi - 8mm