DynaNail Hybrid

GUDID M97026010071400

DynaNail Hybrid, 7mm x 140mm

Medshape, Inc.

Arthrodesis nail

• Primary Device ID: M97026010071400
• NIH Device Record Key: 8b5d9763-1297-4e82-a031-042e1567d038
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DynaNail Hybrid
• Version Model Number: 2601-00-7140
• Company DUNS: 601306413
• Company Name: Medshape, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M97026010071400 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203381

FDA Product Code

• HWC: Screw, 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: 2022-12-08
• Device Publish Date: 2021-04-23

On-Brand Devices [DynaNail Hybrid]

• M97026010071300: DynaNail Hybrid, 7mm x 130mm
• M97026010071200: DynaNail Hybrid, 7mm x 120mm
• M97026010071100: DynaNail Hybrid, 7mm x 110mm
• M97026010071000: DynaNail Hybrid, 7mm x 100mm
• M97026010070900: DynaNail Hybrid, 7mm x 90mm
• M97026010070800: DynaNail Hybrid, 7mm x 80mm
• M97026010070700: DynaNail Hybrid, 7mm x 70mm
• M97026010070600: DynaNail Hybrid, 7mm x 60mm
• M97026010071400: DynaNail Hybrid, 7mm x 140mm