BIOSTEP XT

GUDID 00713980028314

BioStep XT, Size 26, Right, Rate 11

Alps South, LLC

Mechanical-resistance external ankle-foot prosthesis
Primary Device ID00713980028314
NIH Device Record Key5ab952ba-69cc-4534-94f5-2cb0b1237783
Commercial Distribution StatusIn Commercial Distribution
Brand NameBIOSTEP XT
Version Model NumberBSXT-26R-11
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
GS100713980028314 [Primary]

FDA Product Code

ISHComponent, External, Limb, Ankle/Foot

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-01-22
Device Publish Date2025-01-14

On-Brand Devices [BIOSTEP XT]

00713980027232BioStep XT, Size 23, Left, Rate 42
00713980027225BioStep XT, Size 23, Left, Rate 32, Dark
00713980027218BioStep XT, Size 23, Left, Rate 32
00713980027201BioStep XT, Size 23, Left, Rate 31, Dark
00713980027195BioStep XT, Size 23, Left, Rate 31
00713980027188BioStep XT, Size 23, Left, Rate 22, Dark
00713980027171BioStep XT, Size 23, Left, Rate 22
00713980027164BioStep XT, Size 23, Left, Rate 21, Dark
00713980027157BioStep XT, Size 23, Left, Rate 21
00713980027140BioStep XT, Size 23, Left, Rate 11, Dark
00713980027133BioStep XT, Size 23, Left, Rate 11
00713980027126BioStep XT, Size 22, Right, Rate 62, Dark
00713980027119BioStep XT, Size 22, Right, Rate 62
00713980027102BioStep XT, Size 22, Right, Rate 52, Dark
00713980027096BioStep XT, Size 22, Right, Rate 52
00713980027089BioStep XT, Size 22, Right, Rate 42, Dark
00713980027072BioStep XT, Size 22, Right, Rate 42
00713980027065BioStep XT, Size 22, Right, Rate 32, Dark
00713980027058BioStep XT, Size 22, Right, Rate 32
00713980027041BioStep XT, Size 22, Right, Rate 31, Dark
00713980027034BioStep XT, Size 22, Right, Rate 31
00713980027027BioStep XT, Size 22, Right, Rate 22, Dark
00713980027010BioStep XT, Size 22, Right, Rate 22
00713980027003BioStep XT, Size 22, Right, Rate 21, Dark
00713980026990BioStep XT, Size 22, Right, Rate 21
00713980026983BioStep XT, Size 22, Right, Rate 11, Dark
00713980026976BioStep XT, Size 22, Right, Rate 11
00713980026969BioStep XT, Size 22, Left, Rate 62, Dark
00713980026952BioStep XT, Size 22, Left, Rate 62
00713980026945BioStep XT, Size 22, Left, Rate 52, Dark
00713980026938BioStep XT, Size 22, Left, Rate 52
00713980026921BioStep XT, Size 22, Left, Rate 42, Dark
00713980026914BioStep XT, Size 22, Left, Rate 42
00713980026907BioStep XT, Size 22, Left, Rate 32, Dark
00713980026891BioStep XT, Size 22, Left, Rate 32
00713980026884BioStep XT, Size 22, Left, Rate 31, Dark
00713980026877BioStep XT, Size 22, Left, Rate 31
00713980026860BioStep XT, Size 22, Left, Rate 22, Dark
00713980026853BioStep XT, Size 22, Left, Rate 22
00713980026846BioStep XT, Size 22, Left, Rate 21, Dark
00713980026839BioStep XT, Size 22, Left, Rate 21
00713980026822BioStep XT, Size 22, Left, Rate 11, Dark
00713980026815BioStep XT, Size 22, Left, Rate 11
00713980028123BioStep XT, Size 25, Right, Rate 64, Dark
00713980028116BioStep XT, Size 25, Right, Rate 64
00713980028109BioStep XT, Size 25, Right, Rate 53, Dark
00713980028093BioStep XT, Size 25, Right, Rate 53
00713980028086BioStep XT, Size 25, Right, Rate 43, Dark
00713980028079BioStep XT, Size 25, Right, Rate 43
00713980028062BioStep XT, Size 25, Right, Rate 42, Dark

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.