FDA.reportPublic FDA data

CoolJect Targeted-Mist 1-3cc Nook Syringe Holder Accessory

Primary DI
00860010587317
Brand
CoolJect Targeted-Mist 1-3cc Nook Syringe Holder Accessory
Company
Vapocoolshot, Inc
Model
CJ01050-00
Catalog number
CJ01050-00
Device description
CoolJect Targeted-Mist 1-3cc Nook Syringe Holder Accessory
Published
2025-08-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
KZHIntroducer, Syringe Needle
MLYVapocoolant Device

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KZHIntroducer, Syringe NeedleGeneral Hospital2
MLYVapocoolant DeviceUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K201248000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201248000Syringe Holder accessoryVapocoolshot, Inc.2020-08-12MLY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860010587317PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860010587317008600105873178600105873170860010587317

GMDN Terms#

Term, Definition table
TermDefinition
Biopsy syringe holder, reusableA hand-operated device designed to hold a biopsy syringe to facilitate precision aspiration of a tissue specimen through a biopsy needle. The holder is typically made of metal and plastic materials and typically designed as a lightweight, hand-held frame in which the syringe is placed and its piston withdrawn using a sliding handle in the frame; a stopper may be included to prevent further aspiration at a predetermined point. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
032313444
Device count
1
Lot or batch
true
Manufacturing date on label
true

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
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
20860006961507Coolject Topical Anesthetic CanisterVM02000-032023-01-27
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
B33919800010V-CathNeo Medical Inc.KZH2026-03-27
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
05713495000121SKYTROFA Auto-InjectorPhillips-Medisize A/SKZH2025-08-20
05713495000138SKYTROFA Auto-InjectorPhillips-Medisize A/SKZH2025-08-20
57622436104114Glatopaject ®AEROPHARM GmbHKZH2025-08-19
47622436104100Glatopaject ®AEROPHARM GmbHKZH2025-08-19
00860010587331CoolJect Targeted-Mist Topical AnestheticVapocoolshot, IncMLY2025-08-01
00860010587324CoolJect Targeted-Mist Topical AnestheticVapocoolshot, IncMLY2025-08-01
10860010587321CoolJect Targeted-Mist Topical AnestheticVapocoolshot, IncMLY2025-08-01
00850037806058Orbit InserterModular Medical, Inc.KZH2025-07-11
00850037806119MODD1 Starter KitModular Medical, Inc.KZH2025-07-11
00850037806126MODD1 Patient Welcome KitModular Medical, Inc.KZH2025-07-11
00370095000002GripMate™SUN PHARMACEUTICAL INDUSTRIES, INC.KZH2025-05-12