← Back to catalogue

Coolject 1-3cc Syringe Holder Nozzle Accessory

FDA UDI

Class II (US FDA UDI)

by Vapocoolshot, Inc

Identity

Trade Name
Coolject 1-3cc Syringe Holder Nozzle Accessory FDA UDI
Generic Name
Biopsy syringe holder, reusable FDA UDI
Device Name
Coolject 1-3 cc Syringe Holder Nozzle Accessory, One per Box FDA UDI
Model / Reference
VM01000-00 FDA UDI
Description
Coolject 1-3 cc Syringe Holder Nozzle Accessory, One per Box FDA UDI

Identifiers

Primary DI / UDI-DI
00860006961534 FDA UDI
510(k) Number
K201248 FDA UDI
FDA Product Code
KZH FDA UDI
MLY FDA UDI
GMDN Term
Biopsy syringe holder, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.6920 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Biopsy syringe holder, reusable

Coolject 1-3cc Syringe Holder Nozzle Accessory by Vapocoolshot, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Biopsy syringe holder, reusable.

Cleared under the same submission

K201248 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Vapocoolshot, Inc

Sources (1)

  • FDA UDI d3cc9a15-f444-4466-bf84-f5a2c3e59592 34 fields · synced May 31, 2026