ULTRA SEAL LINER

GUDID 00713980035008

Ultra Seal High Ring Cushion Liner Size 32

Alps South, LLC

External limb prosthesis socket liner
Primary Device ID00713980035008
NIH Device Record Key1625c13b-baac-4d86-b75c-254f47c6b12a
Commercial Distribution StatusIn Commercial Distribution
Brand NameULTRA SEAL LINER
Version Model NumberUSHSC32
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
GS100713980035008 [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 Date2025-01-06
Device Publish Date2024-12-27

On-Brand Devices [ULTRA SEAL LINER]

00713980035954Ultra Seal Low Ring Cushion Liner Size 44
00713980035947Ultra Seal Low Ring Cushion Liner Size 41
00713980035930Ultra Seal Low Ring Cushion Liner Size 38
00713980035923Ultra Seal Low Ring Cushion Liner Size 35
00713980035916Ultra Seal Low Ring Cushion Liner Size 32
00713980035909Ultra Seal Low Ring Cushion Liner Size 30
00713980035893Ultra Seal Low Ring Cushion Liner Size 28
00713980035886Ultra Seal Low Ring Cushion Liner Size 26
00713980035879Ultra Seal Low Ring Cushion Liner Size 24
00713980035060Ultra Seal Low Ring Cushion Liner Size 22
00713980035053Ultra Seal Low Ring Cushion Liner Size 20
00713980035046Ultra Seal High Ring Cushion Liner Size 44
00713980035039Ultra Seal High Ring Cushion Liner Size 41
00713980035022Ultra Seal High Ring Cushion Liner Size 38
00713980035015Ultra Seal High Ring Cushion Liner Size 35
00713980035008Ultra Seal High Ring Cushion Liner Size 32
00713980034995Ultra Seal High Ring Cushion Liner Size 30
00713980034988Ultra Seal High Ring Cushion Liner Size 28
00713980034971Ultra Seal High Ring Cushion Liner Size 26
00713980034964Ultra Seal High Ring Cushion Liner Size 24
00713980034957Ultra Seal High Ring Cushion Liner Size 22
00713980034940Ultra Seal High Ring Cushion Liner Size 20
00713980036173Ultra Seal Low Ring Locking Liner Size 44
00713980036166Ultra Seal Low Ring Locking Liner Size 41
00713980036159Ultra Seal Low Ring Locking Liner Size 38
00713980036142Ultra Seal Low Ring Locking Liner Size 35
00713980036135Ultra Seal Low Ring Locking Liner Size 32
00713980036128Ultra Seal Low Ring Locking Liner Size 30
00713980036111Ultra Seal Low Ring Locking Liner Size 28
00713980036104Ultra Seal Low Ring Locking Liner Size 26
00713980036098Ultra Seal Low Ring Locking Liner Size 24
00713980036081Ultra Seal Low Ring Locking Liner Size 22
00713980036074Ultra Seal Low Ring Locking Liner Size 20
00713980036067Ultra Seal High Ring Locking Liner Size 44
00713980036050Ultra Seal High Ring Locking Liner Size 41
00713980036043Ultra Seal High Ring Locking Liner Size 38
00713980036036Ultra Seal High Ring Locking Liner Size 35
00713980036029Ultra Seal High Ring Locking Liner Size 32
00713980036012Ultra Seal High Ring Locking Liner Size 30
00713980036005Ultra Seal High Ring Locking Liner Size 28
00713980035992Ultra Seal High Ring Locking Liner Size 26
00713980035985Ultra Seal High Ring Locking Liner Size 24
00713980035978Ultra Seal High Ring Locking Liner Size 22
00713980035961Ultra Seal High Ring Locking Liner Size 20
00713980037880Ultra Seal Gel Low Ring Locking Liner Size 44-3
00713980037873Ultra Seal Gel Low Ring Locking Liner Size 38-3
00713980037866Ultra Seal Gel Low Ring Locking Liner Size 35-3
00713980037859Ultra Seal Gel Low Ring Locking Liner Size 32-3
00713980037842Ultra Seal Gel Low Ring Locking Liner Size 28-3
00713980037835Ultra Seal Gel Low Ring Locking Liner Size 26-3

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