FDA.reportPublic FDA data

Coolject Topical Anesthetic Canister

Primary DI
20860006961507
Brand
Coolject Topical Anesthetic Canister
Company
Vapocoolshot, Inc
Model
VM02000-03
Device description
Coolject Topical Anesthetic Canister. 3 per box
Published
2023-01-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
MLYVapocoolant Device

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MLYVapocoolant DeviceUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K193349000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K193349000Vapocoolshot MistVapocoolshot, Inc.2020-04-14MLY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860006961527PrimaryGS10
20860006961507Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860006961527008600069615278600069615270860006961527
2086000696150720860006961507

GMDN Terms#

Term, Definition table
TermDefinition
Cold/cool therapy sprayA non-sterile liquid (e.g., alcohol based) in a spray container intended for localized application to the body surface to provide a cooling effect for underlying muscles/joints to reduce pain and swelling typically from sports injuries (cold therapy), and/or for cooling at the skin surface to treat heat rash or hot flushes (cool therapy); it may be intended to be applied to the skin directly or used in combination with a moist-cold pack/bandage (i.e., used to soak the moist-cold pack/bandage). After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
032313444
Device count
3
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
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
00860010587355DentalJect ApplicatorDJ01000-00DJ01000-002025-11-07
00860010587362DentalJect Syringe ConnectorDJ02000-00DJ02000-002025-11-07
00860010587393DentalJect Starter Kit - No Syringe ConnectorDJ06000-00DJ06000-002025-11-07
10860006961524Coolject Topical Anesthetic CanisterVM02000-122023-01-27
20860006961521Coolject Topical Anesthetic CanisterVM02000-242023-01-27
00860006961527Coolject Topical Anesthetic CanisterVM02000-032023-01-27
00860006961503Coolject Topical Anesthetic CanisterVM02000-002023-01-27
00860006961510Coolject 1-3cc Syringe Holder Nozzle AccessoryVM01000-002023-01-27
00860006961534Coolject 1-3cc Syringe Holder Nozzle AccessoryVM01000-002023-01-27
00860006961541Coolject Standard Nozzle AccessoryVM01100-002023-01-27
00860006961558Coolject Standard Nozzle AccessoryVM01100-002023-01-27
00860010587348DentalJect CanisterDJ03000-012025-09-08
00860010587379DentalJect Applicator SetDJ04000-002025-09-08
00860010587386DentalJect Starter KitDJ05000-002025-09-08
00860010587331CoolJect Targeted-Mist Topical AnestheticCJ04050-12CJ04050-122025-08-01
00860010587317CoolJect Targeted-Mist 1-3cc Nook Syringe Holder AccessoryCJ01050-00CJ01050-002025-08-01
00860010587324CoolJect Targeted-Mist Topical AnestheticCJ04050-00CJ04050-002025-08-01
10860010587321CoolJect Targeted-Mist Topical AnestheticCJ04050-12CJ04050-122025-08-01
00860006961596CoolJect Targeted-Mist Topical AnestheticCJ02050-122023-04-28
10860006961500Coolject Topical Anesthetic CanisterVM02000-122023-01-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10723797170615InstaNumbBEUTLICH PHARMACEUTICALS, LLCMLY2026-04-15
10723797170721InstaNumbBEUTLICH PHARMACEUTICALS, LLCMLY2026-04-15
10723797170837InstaNumbBEUTLICH PHARMACEUTICALS, LLCMLY2026-04-15
10723797170943InstaNumbBEUTLICH PHARMACEUTICALS, LLCMLY2026-04-15
00850079280298HexaHexa DentalMLY2026-01-21
10723797806446Hurri-FreezeBEUTLICH PHARMACEUTICALS, LLCMLY2025-12-15
10723797807443Hurri-FreezeBEUTLICH PHARMACEUTICALS, LLCMLY2025-12-15
10723797809447Hurri-FreezeBEUTLICH PHARMACEUTICALS, LLCMLY2025-12-15
20723797806443Hurri-FreezeBEUTLICH PHARMACEUTICALS, LLCMLY2025-12-15
20723797807440Hurri-FreezeBEUTLICH PHARMACEUTICALS, LLCMLY2025-12-15
10723797808440Hurri-FreezeBEUTLICH PHARMACEUTICALS, LLCMLY2025-12-15
20723797809444Hurri-FreezeBEUTLICH PHARMACEUTICALS, LLCMLY2025-12-15
00860010587355DentalJect ApplicatorVapocoolshot, IncMLY2025-11-07
00860010587362DentalJect Syringe ConnectorVapocoolshot, IncMLY2025-11-07
00860010587393DentalJect Starter Kit - No Syringe ConnectorVapocoolshot, IncMLY2025-11-07
00860010587348DentalJect CanisterVapocoolshot, IncMLY2025-09-08
00860010587379DentalJect Applicator SetVapocoolshot, IncMLY2025-09-08
00860010587386DentalJect Starter KitVapocoolshot, IncMLY2025-09-08
00860010587331CoolJect Targeted-Mist Topical AnestheticVapocoolshot, IncMLY2025-08-01
00860010587317CoolJect Targeted-Mist 1-3cc Nook Syringe Holder AccessoryVapocoolshot, IncMLY2025-08-01
00860010587324CoolJect Targeted-Mist Topical AnestheticVapocoolshot, IncMLY2025-08-01
10860010587321CoolJect Targeted-Mist Topical AnestheticVapocoolshot, IncMLY2025-08-01
00860006961596CoolJect Targeted-Mist Topical AnestheticVapocoolshot, IncMLY2023-04-28
00860006961589CoolJect Targeted-Mist Topical AnestheticVapocoolshot, IncMLY2023-04-28
10860006961586CoolJect Targeted-Mist Topical AnestheticVapocoolshot, IncMLY2023-04-28
10860006961524Coolject Topical Anesthetic CanisterVapocoolshot, IncMLY2023-01-27
20860006961521Coolject Topical Anesthetic CanisterVapocoolshot, IncMLY2023-01-27
00860006961527Coolject Topical Anesthetic CanisterVapocoolshot, IncMLY2023-01-27
00860006961503Coolject Topical Anesthetic CanisterVapocoolshot, IncMLY2023-01-27
00860006961510Coolject 1-3cc Syringe Holder Nozzle AccessoryVapocoolshot, IncMLY2023-01-27