FDA.reportPublic FDA data

SACH Foot for Children

Primary DI
04048817485241
Brand
SACH Foot for Children
Company
Streifeneder ortho.production GmbH
Model
30A26/20L
Catalog number
30A26/20L
Device description
SACH Foot for Children with Split Toe, size: 20 cm, side: left, weight: 210 g, height: 63 mm, thread M8, max. body weight: 45 kg
Published
2020-11-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
04048817485241PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048817485241040488174852414048817485241

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Regulatory Flags#

DUNS number
317931954
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04048817530460PeroSupport.tec197R6/L1197R6/L12020-11-02
04048817530521PeroSupport.tec197R6/R1197R6/R12020-11-02
04048817530538PeroSupport.tec197R6/R2197R6/R22020-11-02
04048817530545PeroSupport.tec197R6/L2197R6/L22020-11-02
04048817530552PeroSupport.tec197R6/L3197R6/L32020-11-02
04048817530569PeroSupport.tec197R6/R3197R6/R32020-11-02
04048817530576PeroSupport.tec197R6/L4197R6/L42020-11-02
04048817530583PeroSupport.tec197R6/R4197R6/R42020-11-02
04048817620192PeroSupport.tec197R4/L0197R4/L02020-11-02
04048817620208PeroSupport.tec197R4/L1197R4/L12020-11-02
04048817620215PeroSupport.tec197R4/L2197R4/L22020-11-02
04048817620222PeroSupport.tec197R4/L4197R4/L42020-11-02
04048817620239PeroSupport.tec197R4/R0197R4/R02020-11-02
04048817620246PeroSupport.tec197R4/R1197R4/R12020-11-02
04048817620253PeroSupport.tec197R4/R2197R4/R22020-11-02
04048817620260Padding Set for PeroSupport.tec197R10197R102020-11-02
04048817378772PeroSupport.tec197R4/L3197R4/L32020-10-15
04048817378789PeroSupport.tec197R4/R3197R4/R32020-10-15
04048817378796PeroSupport.tec197R4/R4197R4/R42020-10-15
04048817574976Transtibial Exhaust Valve active.valve6P506P502020-11-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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00195411212231ScoutCOLLEGE PARK INDUSTRIES, INC.ISH2024-06-19
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00195411212255ScoutCOLLEGE PARK INDUSTRIES, INC.ISH2024-06-19
00195411212262ScoutCOLLEGE PARK INDUSTRIES, INC.ISH2024-06-19
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00195411212309ScoutCOLLEGE PARK INDUSTRIES, INC.ISH2024-06-19
00195411212316ScoutCOLLEGE PARK INDUSTRIES, INC.ISH2024-06-19
00195411419470ScoutCOLLEGE PARK INDUSTRIES, INC.ISH2024-06-19