FDA.reportPublic FDA data

DYNAMIC FREEZE

Primary DI
00860177000681
Brand
DYNAMIC FREEZE
Company
ECOTEC MANUFACTURING, INC.
Model
ZPL FR-6745
Device description
Medical Freeze Spray
Published
2025-07-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00860177000681PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860177000681008601770006818601770006810860177000681

GMDN Terms#

Term, Definition table
TermDefinition
Cryogenic tissue spray IVDA refrigerant (e.g., tetrafluoroethane) in a spray container intended to be used for the rapid freezing of a tissue biopsy or cytology specimen, to facilitate sectioning with a cryotome for subsequent in vitro diagnostic analysis. It is not intended to be used as a tissue fixative. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

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
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
00852509006027COLD AS ICE2502017-11-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860009716124SPRAY / PUMPJhk, Inc.IFI2023-07-28
00860009716155SPRAY / PUMPJhk, Inc.IFI2023-07-28
00860177000636Max Pro Medical Freeze SprayECOTEC MANUFACTURING, INC.IFI2018-08-15
00852509006027COLD AS ICEECOTEC MANUFACTURING, INC.IFI2017-11-21