REINFORCED SLEEVE

GUDID 00713980037392

Black Preflex Sleeve Size 29 w/Reinforced Fabric

Alps South, LLC

External lower-limb prosthesis suspensory component, non-powered
Primary Device ID00713980037392
NIH Device Record Key861e1697-21ee-42a3-aecd-ffc5c394e118
Commercial Distribution StatusIn Commercial Distribution
Brand NameREINFORCED SLEEVE
Version Model NumberRFX29-3BL
Company DUNS824697569
Company NameAlps South, LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100713980037392 [Primary]

FDA Product Code

ISSProsthesis, Thigh Socket, External Component

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-04-15
Device Publish Date2025-04-07

On-Brand Devices [REINFORCED SLEEVE]

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