FDA.reportPublic FDA data

Neoflex

Primary DI
00850013242597
Brand
Neoflex
Company
CYPRESS ADAPTIVE, LLC
Model
CA700-FP-T4
Catalog number
CA700-FP-T4
Device description
Prosthetic suspension sleeve with knee pad reinforcement in tan color and size 4.0.
Published
2019-12-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
ISSProsthesis, Thigh Socket, External Component

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ISSProsthesis, Thigh Socket, External ComponentPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850013242597PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850013242597008500132425978500132425970850013242597

GMDN Terms#

Term, Definition table
TermDefinition
Prosthesis suspension systemA group of devices used to hold/fasten a prosthesis to the body. The devices include locking pins, belts, silicone or neoprene sleeves, wedges, clamps, and suction sockets.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080277500
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850013242092Aria safety barb (US)CA300-ASBCA300-ASB2019-12-17
00850013242108Aria Safety Barb (metric)CA300-ASBMCA300-ASBM2019-12-17
00850013242894Aria Universal Mini Valve Molding DummyCA100-MVDCA100-MVD2023-10-05
00850013242887Aria Universal Mini Valve KeyCA100-MVK2022-10-01
00850013242016Aria Mini ValveCA100-MVCA100-MV2021-08-11
00085001342106Aria Mini ValveCA100-MVCA100-MV2021-08-11
00850013242009Aria Valve (US)CA200-AVCA200-AV2019-12-17
00850013242023Aria valve (metric)CA200-AVMCA200-AVM2019-12-17
00850013242030Aria Valve Plus (US)CA200-AVPCA200-AVP2019-12-17
00850013242047Aria valve plus (metric)CA200AVPMCA200AVPM2019-12-17
00850013242054Aria E-valveCA200-AECA200-AE2019-12-17
00850013242061Aria plate valveCA300-APVCA300-APV2019-12-17
00850013242078Aria HV Plate Valve CA300-AHVPCA300-AHVP2019-12-17
00850013242085Aria Hybrid ValveCA300-HYVCA300-HYV2019-12-17
00850013242115Aria AK ValveCA100-AKCA100-AK2019-12-17
00850013242122Aria AK valve insertCA100-VICA100-VI2019-12-17
00850013242139Cypress 4-hole tie-in plateCA400-TIPCA400-TIP2019-12-17
00850013242146Cypress low profile 4-hole tie-in plateCA400-LPCA400-LP2019-12-17
00850013242153Aria auto expulsion valve insertCA400-VCA400-V2019-12-17
00850013242160Aria HV Valve insert CA400-HVCA400-HV2019-12-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04262429650563Lumo Spacer, STD-Amacu4 GmbHISS2025-11-23
04262429650648Lumo Module Connectormacu4 GmbHISS2025-11-23
04262429650655Lumo Spacer, STD-Bmacu4 GmbHISS2025-11-23
04262429650662Lumo Spacer, STD-Cmacu4 GmbHISS2025-11-23
04262429650679Lumo Spacer, STD-Dmacu4 GmbHISS2025-11-23
04262429650686Lumo Spacer, STD-Emacu4 GmbHISS2025-11-23
00713980038023ULTRA SEAL LINERAlps South, LLCISS2025-07-03
00713980038030ULTRA SEAL LINERAlps South, LLCISS2025-07-03
00713980038047ULTRA SEAL LINERAlps South, LLCISS2025-07-03
00713980038054ULTRA SEAL LINERAlps South, LLCISS2025-07-03
00713980038061ULTRA SEAL LINERAlps South, LLCISS2025-07-03
00713980038078ULTRA SEAL LINERAlps South, LLCISS2025-07-03
00713980038085ULTRA SEAL LINERAlps South, LLCISS2025-07-03
00713980038092ULTRA SEAL LINERAlps South, LLCISS2025-07-03
00713980038108ULTRA SEAL LINERAlps South, LLCISS2025-07-03
00713980038115ULTRA SEAL LINERAlps South, LLCISS2025-07-03
00713980038122ULTRA SEAL LINERAlps South, LLCISS2025-07-03
00713980038139ULTRA SEAL LINERAlps South, LLCISS2025-07-03
00713980038146ULTRA SEAL LINERAlps South, LLCISS2025-07-03
00713980038153ULTRA SEAL LINERAlps South, LLCISS2025-07-03
00713980038160ULTRA SEAL LINERAlps South, LLCISS2025-07-03
00713980038177ULTRA SEAL LINERAlps South, LLCISS2025-07-03
00713980038184ULTRA SEAL LINERAlps South, LLCISS2025-07-03
00713980038191ULTRA SEAL LINERAlps South, LLCISS2025-07-03
00713980038207ULTRA SEAL LINERAlps South, LLCISS2025-07-03
00713980038214ULTRA SEAL LINERAlps South, LLCISS2025-07-03
00713980038221ULTRA SEAL LINERAlps South, LLCISS2025-07-03
00713980038238ULTRA SEAL LINERAlps South, LLCISS2025-07-03
00713980038245ULTRA SEAL LINERAlps South, LLCISS2025-07-03
00713980038252ULTRA SEAL LINERAlps South, LLCISS2025-07-03