FDA.reportPublic FDA data

Soleus

Primary DI
00195411176809
Brand
Soleus
Company
COLLEGE PARK INDUSTRIES, INC.
Model
SO LCM 25N D75
Device description
Soleus Foot, Left, Caucasian, Midnight Black Housing, 25cm, Narrow, Category 75
Published
2023-09-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
ISHComponent, External, Limb, Ankle/Foot

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ISHComponent, External, Limb, Ankle/FootPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00195411176809PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00195411176809001954111768091954111768090195411176809

GMDN Terms#

Term, Definition table
TermDefinition
Mechanical-resistance external ankle-foot prosthesisA mechanical device which is a component of an external lower limb prosthesis designed to functionally replace, in part or total, an absent foot and/or ankle, wherein the principle of operation for dorsiflexion/plantar flexion control is based on media-free mechanical resistance (i.e., mechanical friction/elastic deflection with no fluid or gas operating media). The device may have various designs and functional features (e.g., SACH, SAFE, partial-foot, energy-storing carbon fibre spring blade type, adjustable heel height, split/sandal toe) for support during a variety of activities.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-728-7950orders@college-park.com

Regulatory Flags#

DUNS number
623191137
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841747186936Aura PlusAHKA 5002026-01-29
00841747186943Aura PlusAHKA 5502026-01-29
00195411458905IconIC CB G2025-05-28
00841747186912Endoskeletal ComponentsTA WT250 302025-05-28
00841747186929Endoskeletal ComponentsTA WT430 302025-05-28
00841747183973SterlingSLK G3L US12024-11-01
00841747183997SterlingSLK G3C UL22024-11-01
00841747184000SterlingSLK G3C UM+22024-11-01
00841747184017SterlingSLK G3C UM22024-11-01
00841747184024SterlingSLK G3C US22024-11-01
00841747184031SterlingSLK G9L UXL22024-11-01
00841747184048SterlingSLK G9L UL+22024-11-01
00841747184055SterlingSLK G9L UL22024-11-01
00841747184062SterlingSLK G9L UM+22024-11-01
00841747184079SterlingSLK G9L UM22024-11-01
00841747184086SterlingSLK G9L US22024-11-01
00841747184093SterlingSLK G6L UXL22024-11-01
00841747184109SterlingSLK G6L UL+22024-11-01
00841747184116SterlingSLK G6L UL22024-11-01
00841747184123SterlingSLK G6L UM+22024-11-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00195411212033ScoutCOLLEGE PARK INDUSTRIES, INC.ISH2024-06-19
00195411212040ScoutCOLLEGE PARK INDUSTRIES, INC.ISH2024-06-19
00195411212057ScoutCOLLEGE PARK INDUSTRIES, INC.ISH2024-06-19
00195411212064ScoutCOLLEGE PARK INDUSTRIES, INC.ISH2024-06-19
00195411212071ScoutCOLLEGE PARK INDUSTRIES, INC.ISH2024-06-19
00195411212088ScoutCOLLEGE PARK INDUSTRIES, INC.ISH2024-06-19
00195411212095ScoutCOLLEGE PARK INDUSTRIES, INC.ISH2024-06-19
00195411212101ScoutCOLLEGE PARK INDUSTRIES, INC.ISH2024-06-19
00195411212118ScoutCOLLEGE PARK INDUSTRIES, INC.ISH2024-06-19
00195411212125ScoutCOLLEGE PARK INDUSTRIES, INC.ISH2024-06-19
00195411212132ScoutCOLLEGE PARK INDUSTRIES, INC.ISH2024-06-19
00195411212149ScoutCOLLEGE PARK INDUSTRIES, INC.ISH2024-06-19
00195411212156ScoutCOLLEGE PARK INDUSTRIES, INC.ISH2024-06-19
00195411212163ScoutCOLLEGE PARK INDUSTRIES, INC.ISH2024-06-19
00195411212170ScoutCOLLEGE PARK INDUSTRIES, INC.ISH2024-06-19
00195411212187ScoutCOLLEGE PARK INDUSTRIES, INC.ISH2024-06-19
00195411212194ScoutCOLLEGE PARK INDUSTRIES, INC.ISH2024-06-19
00195411212200ScoutCOLLEGE PARK INDUSTRIES, INC.ISH2024-06-19
00195411212217ScoutCOLLEGE PARK INDUSTRIES, INC.ISH2024-06-19
00195411212224ScoutCOLLEGE PARK INDUSTRIES, INC.ISH2024-06-19
00195411212231ScoutCOLLEGE PARK INDUSTRIES, INC.ISH2024-06-19
00195411212248ScoutCOLLEGE PARK INDUSTRIES, INC.ISH2024-06-19
00195411212255ScoutCOLLEGE PARK INDUSTRIES, INC.ISH2024-06-19
00195411212262ScoutCOLLEGE PARK INDUSTRIES, INC.ISH2024-06-19
00195411212279ScoutCOLLEGE PARK INDUSTRIES, INC.ISH2024-06-19
00195411212286ScoutCOLLEGE PARK INDUSTRIES, INC.ISH2024-06-19
00195411212293ScoutCOLLEGE PARK INDUSTRIES, INC.ISH2024-06-19
00195411212309ScoutCOLLEGE PARK INDUSTRIES, INC.ISH2024-06-19
00195411212316ScoutCOLLEGE PARK INDUSTRIES, INC.ISH2024-06-19
00195411419470ScoutCOLLEGE PARK INDUSTRIES, INC.ISH2024-06-19