FDA.reportPublic FDA data

Scrip Hessco

Primary DI
00812433023057
Brand
Scrip Hessco
Company
Scriphessco
Model
232 0163
Device description
"Scrip Hessco Reusable Hot/Cold Packs 5"" X 10.25"""
Published
2017-07-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
IMEPack, Hot Or Cold, Reuseable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IMEPack, Hot Or Cold, ReusablePhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812433023057PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812433023057008124330230578124330230570812433023057

GMDN Terms#

Term, Definition table
TermDefinition
Hot/cold therapy pack, reusableA non-sterile device intended to be applied with or without pressure to the body surface (i.e., non-invasively) to provide heat and/or cold therapy for the skin and/or underlying tissues in the treatment of musculoskeletal pain and discomfort (e.g., from sports injuries or rheumatism). It consists of a compact envelope filled with a thermally-retentive material (e.g., silicate-based gel) that can be heated and/or cooled. It may be shaped/sized to fit a specific anatomy or include a strap; it is not intended to support the neck. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
6307717459lrogus@scripco.com

Regulatory Flags#

DUNS number
054152269
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00812433023064Scrip Hessco663 00042017-06-05
00812433025204Scrip Hessco663 00122017-06-05
00812433029295Scrip Hessco663 00192017-06-05
00812433023071Scrip Hessco672 00102017-05-23
00812433023088Scrip Hessco672 00182017-05-23
00812433023095Scrip Hessco672 00232017-05-23
00812433023101Scrip Hessco672 00282017-05-23
00812433023118Scrip Hessco672 01922017-05-23
00812433023125Scrip Hessco672 01932017-05-23
00812433020001Scrip Hessco663 00612019-10-16

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00197998026164Solventum™Solventum US LLCIME2026-02-15
00197998026614Solventum™Solventum US LLCIME2026-02-15
00810178884735ViveVIVE HEALTH LLCIME2025-12-05
00810113683065ManaEZ ROM Ice ShortManamed, Inc.IME2025-10-17
00810113683515ManaEZ Hip Ice CureTechManamed, Inc.IME2025-10-03
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00810113683539ManaEZ Shoulder Ice CureTechManamed, Inc.IME2025-10-03
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00810113683676Cold Compression Wrap, Pro-Knee WrapManamed, Inc.IME2025-09-26
00810113683683Cold Compression Wrap, Pro-Shoulder WrapManamed, Inc.IME2025-09-26
00810113683706Cold Compression Wrap, Pro-Ankle Wrap-WLManamed, Inc.IME2025-09-26
00810113683713Cold Compression Wrap, Pro-Shoulder Wrap-WLManamed, Inc.IME2025-09-26
00810113683720Cold Compression Wrap, Pro-Knee Wrap-WLManamed, Inc.IME2025-09-26
00810113683737Cold Compression Wrap, Pro-Hip Wrap-WLManamed, Inc.IME2025-09-26
00810113683744Cold Compression Wrap, Pro-Back Wrap-WLManamed, Inc.IME2025-09-26
00850073571101American Hospital SupplyAmerican Hospital Supply LLCIME2025-07-28
00850073571118American Hospital SupplyAmerican Hospital Supply LLCIME2025-07-28
00627394040018Pain CakesDrive Devilbiss HealthcareIME2025-06-03
00627394040056Pain CakesDrive Devilbiss HealthcareIME2025-06-03
00627394040063Pain CakesDrive Devilbiss HealthcareIME2025-06-03