Formthotics

GUDID 09419430002316

Formthotics Med L/Volume Single Medium (Perf) - S

FOOT SCIENCE INTERNATIONAL LIMITED

Orthotic insole, prefabricated, antimicrobial

• Primary Device ID: 09419430002316
• NIH Device Record Key: bcb525f2-79b3-4d56-97c9-dea6ec54379c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Formthotics
• Version Model Number: FM01-LvSmBpGr-SM
• Company DUNS: 590255113
• Company Name: FOOT SCIENCE INTERNATIONAL LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	09419430002316 [Primary]

FDA Product Code

• IQI: Orthosis, Limb Brace

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-02-09
• Device Publish Date: 2024-02-01

On-Brand Devices [Formthotics]

• 09419430004334: Metatarsal Domes Black Self Adhesive - 2
• 09419430004327: Metatarsal Domes Black Self Adhesive - 1
• 09419430004129: Medium Rearfoot Wedges Self Adhesive - S
• 09419430012452: 3D Sample Pack Self Adhesive - M
• 09419430012407: 3D Reversible Forefoot Wedge S.A - L
• 09419430012391: 3D Reversible Forefoot Wedge S.A - M
• 09419430012384: 3D Reversible Forefoot Wedge S.A - S
• 09419430012346: 3D Longitudinal Arch Pads S.A. - L
• 09419430012339: 3D Longitudinal Arch Pads S.A - M
• 09419430012322: 3D Longitudinal Arch Pads S.A - S
• 09419430012285: 3D Tri-plane Rearfoot Wedge S.A - L
• 09419430012278: 3D Tri-plane Rearfoot Wedge S.A - M
• 09419430012261: 3D Tri-plane Rearfoot Wedge S.A - S
• 09419430012223: 3D Heel Raisers Self Adhesive - L
• 09419430012216: 3D Heel Raisers Self Adhesive - M
• 09419430012209: 3D Heel Raisers Self Adhesive - S
• 09419430004976: Express Kit Full Length Red - L
• 09419430004969: Express Kit Full Length Red - XS
• 09419430004952: Express Kit Full Length Red - S
• 09419430004945: Express Kit Full Length Red - M
• 09419430004938: Express Kit Full Length Red - XL
• 09419430004921: Express Kit Full Length Red - K
• 09419430004914: Express Kit Full Length Blue - L
• 09419430004907: Express Kit Full Length Blue - XS
• 09419430004891: Express Kit Full Length Blue - S
• 09419430004884: Express Kit Full Length Blue - M
• 09419430004877: Express Kit Full Length Blue - XL
• 09419430004860: Express Kit Full Length Blue - K
• 09419430004853: Express Kit 3/4 Length Blue - L
• 09419430004846: Express Kit 3/4 Length Blue - XS
• 09419430004839: Express Kit 3/4 Length Blue - S
• 09419430004822: Express Kit 3/4 Length Blue - M
• 09419430004815: Express Kit 3/4 Length Blue - XL
• 09419430004808: Express Kit 3/4 Length Blue - K
• 09419430004792: Express Kit 3/4 Length Red - L
• 09419430004785: Express Kit 3/4 Length Red - XS
• 09419430004778: Express Kit 3/4 Length Red - S
• 09419430004761: Express Kit 3/4 Length Red - M
• 09419430004754: Express Kit 3/4 Length Red - XL
• 09419430004747: Express Kit 3/4 Length Red - K
• 09419430004297: Hard Arch Pads Plain - L
• 09419430004280: Hard Arch Pads Plain - M
• 09419430004273: Hard Arch Pads Plain - S
• 09419430004266: Hard Arch Pads Self Adhesive - L
• 09419430004259: Hard Arch Pads Self Adhesive - M
• 09419430004242: Hard Arch Pads Self Adhesive - S
• 09419430004112: High Heel Raisers Plain - L
• 09419430004105: High Heel Raisers Plain - M
• 09419430004099: High Heel Raisers Plain - S
• 09419430004082: High Heel Raisers Self Adhesive - L