FDA.reportPublic FDA data

Silvercrest

Primary DI
14055334351192
Brand
Silvercrest
Company
LIDL US, LLC
Model
SKH60A1
Catalog number
238.20
Device description
SKH60A Heat Pad Art. No. 238.20 IAN 387488_2101
Published
2021-10-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
IRTPad, Heating, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IRTPad, Heating, PoweredPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14055334351192PackageGS15In Commercial Distribution
04055334351195PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1405533435119214055334351192
04055334351195040553343511954055334351195

GMDN Terms#

Term, Definition table
TermDefinition
Electric pad localized-body heating systemAn assembly of mains electricity (AC-powered) devices designed for the transcutaneous application of heat to a localized body site (e.g., joint, limb) to relieve musculoskeletal pain. It consists of an electric heating pad typically made of synthetic fabric materials, and a hand-held control unit used to regulate and monitor the heat. It is intended for use in the home or a clinical setting.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079389709
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04055332060105SilvercrestIAN: 391892_2201656.892022-11-20
14055332060102SilvercrestIAN: 391892_2201656.892022-11-20
04056489267393Tampons by LidlBLIXC362021-02-28
04056489466642Tampons by LidlBLIGR362021-05-29
04056489466659Tampons by LidlBLIGS362021-02-28
04056232708227SilvercrestIAN 326857_1901453.752019-08-19
14056232708224SilvercrestIAN 326857_1901453.752019-08-19
04055334330404SilvercrestIAN 387871_2101454.122021-08-30
04055334351188SilvercrestSWKK60A1238.192021-10-31
04055334351195SilvercrestSKH60A1238.202021-10-31
04055334216562SilvercrestSSHK60E5 (Grey)218.632021-10-31
04055334216579SilvercrestSSHK60E5 (Beige)218.632021-10-31
14055334351185SilvercrestSWKK60A1238.192021-10-31
04055334329453SilvercrestIAN 366721_2101 - SBF77 Black760.622021-10-08
04055334329460SilvercrestIAN 366721_2101 - SBF77 White760.632021-10-08
04055334330084SilvercrestIAN 387870_2101793.992021-08-30
04055334329484SilvercrestIAN: 366723_2101653.182021-06-30
07290016625110Tampons by LidlBLIGR362021-02-28
14056489267390Tampons by LidlBLIXC362021-02-28
14056489466656Tampons by LidlBLIGS362021-02-28

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Primary DI, Brand, Company table
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00810110200562BeurerBEURER NORTH AMERICA, L.P.IRT2026-06-09
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00850087490184AMOOSChangsha Yuhong Trading Co., LtdIRT2026-06-09
00041298995326DMID-M-S HOLDINGS, INC.IRT2026-06-05
00622356691161Shark FacialPro GlowSharkNinja Operating LLCIRT2026-06-02
00622356699631Shark FacialPro GlowSharkNinja Operating LLCIRT2026-06-02
00622356703048Shark FacialPro GlowSharkNinja Operating LLCIRT2026-06-02
00622356704885Shark™ DePuffi™SharkNinja Operating LLCIRT2026-06-02
00622356704953Shark™ DePuffi™SharkNinja Operating LLCIRT2026-06-02
00622356710664Shark FacialPro GlowSharkNinja Operating LLCIRT2026-06-02
00622356710718Shark FacialPro GlowSharkNinja Operating LLCIRT2026-06-02
00622356712200Shark™ DePuffi™SharkNinja Operating LLCIRT2026-06-02
00622356736633Shark FacialPro GlowSharkNinja Operating LLCIRT2026-06-02
00840295411637TherabodyTherabody, Inc.IRT2026-06-01
00041298995043DMID-M-S HOLDINGS, INC.IRT2025-12-30
09413000135374Flowpresso Compression DeviceMEDELLA HEALTH LIMITEDIRT2025-10-16
00041298991960DMID-M-S HOLDINGS, INC.IRT2025-06-12
00031262116291HomedicsHuizhou XINYI Technology Co., LTDIRT2025-02-01
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00031262116666HomedicsHuizhou XINYI Technology Co., LTDIRT2024-12-31
00031262109507HomedicsHuizhou XINYI Technology Co., LTDIRT2024-11-12
00031262113306HomedicsFKA DISTRIBUTING CO., LLCIRT2024-09-30
00031262115416HomedicsFKA DISTRIBUTING CO., LLCIRT2024-09-30
00031262115379HomedicsFKA DISTRIBUTING CO., LLCIRT2024-08-30
00031262115386HomedicsFKA DISTRIBUTING CO., LLCIRT2024-08-30
00031262115393HomedicsFKA DISTRIBUTING CO., LLCIRT2024-08-30
00031262115423HomedicsFKA DISTRIBUTING CO., LLCIRT2024-08-30
00031262115768HomedicsFKA DISTRIBUTING CO., LLCIRT2024-08-30
00041298991953DMID-M-S HOLDINGS, INC.IRT2024-02-28
B311PETNHTPR0PURE ENRICHMENTBEAR DOWN CONSULTINGIRT2023-12-15