FDA.reportPublic FDA data

COLD AS ICE

Primary DI
00852509006027
Brand
COLD AS ICE
Company
ECOTEC MANUFACTURING, INC.
Model
250
Device description
Endo Freeze Spray
Published
2017-11-21
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
IFISprays, Synthetic, Smear

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IFISprays, Synthetic, SmearPathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852509006058PackageGS112In Commercial Distribution
00852509006027PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852509006058008525090060588525090060580852509006058
00852509006027008525090060278525090060270852509006027

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
2547724661savetime@wonderfill.com

Regulatory Flags#

DUNS number
121411859
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850080491010Marie ReikoAB10012025-10-13
00850080491003Marie ReikoAB20012025-10-13
00850080491065Dental City41-2052026-05-14
00850080491058Darby Dental Supply52548992026-05-07
00850080491034Primo Dental ProductsRE152SP2025-11-26
00850080491027Advance Dental Products8000012025-10-21
00860177000681DYNAMIC FREEZEZPL FR-67452025-07-29
00860177000698Allure OrthoFR-3151622025-07-29
00817744022720Primo FreezeRE100SP2024-10-02
00752080000035SkyChoice Polar-FreezeKY10602024-09-25
00752080000028Hexa FreezeHFE-00012024-09-24
00752080000011RMH3 Dental001-11002024-08-19
00810132807435HOUSE BRAND DENTISTRY HSB-1021252024-03-18
00860177000629ENDODONTIC SPRAY#ENSP2018-02-28
D771412051WINTERGREEN FREEZE SPRAY41-2052023-10-31
00860177000643Endodontic Specialists of Northern Colorado Endo IceMF-3164472019-03-11
10860177000640Endodontic Specialists of Northern Colorado Endo IceMF-3164472019-03-11
00860177000636Max Pro Medical Freeze SprayMPMF-65672018-08-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860177000681DYNAMIC FREEZEECOTEC MANUFACTURING, INC.IFI2025-07-29
00860009716124SPRAY / PUMPJhk, Inc.IFI2023-07-28
00860009716155SPRAY / PUMPJhk, Inc.IFI2023-07-28
00860177000636Max Pro Medical Freeze SprayECOTEC MANUFACTURING, INC.IFI2018-08-15