REINFORCED SLEEVE

GUDID 00713980037361

Black Preflex Sleeve Size 20 w/Reinforced Fabric

Alps South, LLC

External lower-limb prosthesis suspensory component, non-powered

• Primary Device ID: 00713980037361
• NIH Device Record Key: bb0c7ae2-6133-4958-a65e-8ca322bf8e31
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: REINFORCED SLEEVE
• Version Model Number: RFX20-3BL
• Company DUNS: 824697569
• Company Name: Alps South, LLC
• 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	00713980037361 [Primary]

FDA Product Code

• ISS: Prosthesis, Thigh Socket, External Component

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: 2025-04-15
• Device Publish Date: 2025-04-07

On-Brand Devices [REINFORCED SLEEVE]

• 00713980033516: Reinforced Sleeve Flex Gray Size 32 3mm
• 00713980033509: Reinforced Sleeve Flex Gray Size 29 3mm
• 00713980033493: Reinforced Sleeve Flex Gray Size 26 3mm
• 00713980033486: Reinforced Sleeve Flex Gray Size 23 3mm
• 00713980033479: Reinforced Sleeve Flex Gray Size 20 3mm
• 00713980033462: Reinforced Sleeve Straight Gray Size 44 3mm
• 00713980033455: Reinforced Sleeve Straight Gray Size 38 3mm
• 00713980033448: Reinforced Sleeve Straight Gray Size 32 3mm
• 00713980033431: Reinforced Sleeve Straight Gray Size 28 3mm
• 00713980033424: Reinforced Sleeve Straight Gray Size 26 3mm
• 00713980033417: Reinforced Sleeve Straight Gray Size 24 3mm
• 00713980033400: Reinforced Sleeve Straight Gray Size 20 3mm
• 00713980037408: Black Preflex Sleeve Size 32 w/Reinforced Fabric
• 00713980037392: Black Preflex Sleeve Size 29 w/Reinforced Fabric
• 00713980037385: Black Preflex Sleeve Size 26 w/Reinforced Fabric
• 00713980037378: Black Preflex Sleeve Size 23 w/Reinforced Fabric
• 00713980037361: Black Preflex Sleeve Size 20 w/Reinforced Fabric