FDA.reportPublic FDA data

CanalPro Color Syringes

Primary DI
26974843120141
Brand
CanalPro Color Syringes
Company
ZOGEAR Medical Co., Ltd.
Model
CanalPro Color Syringes (5 ml) red
Published
2023-04-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
EICSyringe, Periodontic, Endodontic, Irrigating

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EICSyringe, Periodontic, Endodontic, IrrigatingDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
26974843120141PackageGS124In Commercial Distribution
16974843120144PrimaryGS10
06974843120147Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2697484312014126974843120141
1697484312014416974843120144
06974843120147069748431201476974843120147

GMDN Terms#

Term, Definition table
TermDefinition
Dental impression material syringe, single-useA non-sterile, hand-held manual dental instrument designed to inject impression material into an impression tray or directly into a patient?s mouth. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
710958353
Device count
50
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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
16974843120106CanalPro Color SyringesCanalPro Color Syringes (10 ml) red2023-04-20
16974843120113CanalPro Color SyringesCanalPro Color Syringes (10 ml) blue2023-04-20
16974843120120CanalPro Color SyringesCanalPro Color Syringes (10 ml) yellow2023-04-20
16974843120137CanalPro Color SyringesCanalPro Color Syringes (10 ml) white2023-04-20
16974843120144CanalPro Color SyringesCanalPro Color Syringes (5 ml) red2023-04-20
16974843120151CanalPro Color SyringesCanalPro Color Syringes (5 ml) blue2023-04-20
16974843120168CanalPro Color SyringesCanalPro Color Syringes (5 ml) yellow2023-04-20
16974843120175CanalPro Color SyringesCanalPro Color Syringes (5 ml) white2023-04-20
26974843120103CanalPro Color SyringesCanalPro Color Syringes (10 ml) red2023-04-20
26974843120110CanalPro Color SyringesCanalPro Color Syringes (10 ml) blue2023-04-20
26974843120127CanalPro Color SyringesCanalPro Color Syringes (10 ml) yellow2023-04-20
26974843120134CanalPro Color SyringesCanalPro Color Syringes (10 ml) white2023-04-20
26974843120158CanalPro Color SyringesCanalPro Color Syringes (5 ml) blue2023-04-20
26974843120165CanalPro Color SyringesCanalPro Color Syringes (5 ml) yellow2023-04-20
26974843120172CanalPro Color SyringesCanalPro Color Syringes (5 ml) white2023-04-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G149TBSB71040TBS BASICSACME ENTERPRISE.EIC2026-05-22
00371347023466Advance Dental ProductsThe Atlanta Dental Supply CompanyEIC2026-04-14
00371347023473Advance Dental ProductsThe Atlanta Dental Supply CompanyEIC2026-04-14
G1493807003TBS DentalACME ENTERPRISE.EIC2026-03-02
00850014374983MARK3®CARGUS INTERNATIONAL, INCEIC2026-02-05
00850014374990MARK3®CARGUS INTERNATIONAL, INCEIC2026-02-05
00850440008339IrriGatorEngineered Endodontics, LLCEIC2026-01-02
00850440008346IrriGatorEngineered Endodontics, LLCEIC2026-01-02
00850440008353IrriGatorEngineered Endodontics, LLCEIC2026-01-02
00850440008360IrriGatorEngineered Endodontics, LLCEIC2026-01-02
00850440008377IrriGatorEngineered Endodontics, LLCEIC2026-01-02
00850440008384IrriGatorEngineered Endodontics, LLCEIC2026-01-02
00850440008391ES Cap TipsEngineered Endodontics, LLCEIC2026-01-02
00850440008513ES VacEngineered Endodontics, LLCEIC2026-01-02
00850440008520ES VacEngineered Endodontics, LLCEIC2026-01-02
00850440008537ES VacEngineered Endodontics, LLCEIC2026-01-02
00850440008551JS IrriGator Engineered Endodontics, LLCEIC2026-01-02
00850440008568JS IrriGator Engineered Endodontics, LLCEIC2026-01-02
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00810118106545Avalon Biomed Clear Flex Tips - 40 PackNUSMILE, LTD.EIC2025-07-15
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