MC-Subtalar™ II FH39301S

GUDID 04048266163011

MC-Subtalar™ II Screw 10 30 T20 stainless steel

Merete GmbH

Subtalar implant, non-bioabsorbable

• Primary Device ID: 04048266163011
• NIH Device Record Key: fcd55fbe-17e0-4361-8829-840b14f258a2
• Commercial Distribution Discontinuation: 2020-11-16
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: MC-Subtalar™ II
• Version Model Number: 10 30 T20
• Catalog Number: FH39301S
• Company DUNS: 313267265
• Company Name: Merete GmbH
• 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: 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: 630-613-7182
• Email: service@merete-medical.com
• Phone: 630-613-7182
• Email: service@merete-medical.com
• Phone: 630-613-7182
• Email: service@merete-medical.com
• Phone: 630-613-7182
• Email: service@merete-medical.com
• Phone: 630-613-7182
• Email: service@merete-medical.com
• Phone: 630-613-7182
• Email: service@merete-medical.com
• Phone: 630-613-7182
• Email: service@merete-medical.com
• Phone: 630-613-7182
• Email: service@merete-medical.com
• Phone: 630-613-7182
• Email: service@merete-medical.com
• Phone: 630-613-7182
• Email: service@merete-medical.com
• Phone: 630-613-7182
• Email: service@merete-medical.com

Device Dimensions

• Length: 30 Millimeter
• Outer Diameter: 10 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 10 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 10 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 10 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 10 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 10 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 10 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 10 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 10 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 10 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 10 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	04048266163011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160548

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: 6
• Public Version Date: 2022-11-28
• Device Publish Date: 2016-06-10

On-Brand Devices [MC-Subtalar™ II ]

• 04048266163042: MC-Subtalar™ II Screw 10 35 T20 stainless steel
• 04048266163035: MC-Subtalar™ II Screw 8 35 T20 stainless steel
• 04048266163028: MC-Subtalar™ II Screw 6 35 T20 stainless steel
• 04048266163011: MC-Subtalar™ II Screw 10 30 T20 stainless steel
• 04048266163004: MC-Subtalar™ II Screw 8 30 T20 stainless steel
• 04048266162991: MC-Subtalar™ II Screw 6 30 T20 stainless steel
• 04048266162984: MC-Subtalar™ II Screw 10 25 T20 stainless steel
• 04048266162977: MC-Subtalar™ II Screw 8 25 T20 stainless steel
• 04048266162960: MC-Subtalar™ II Screw 6 25 T20 stainless steel