FDA.reportPublic FDA data

baixin

Primary DI
06936018502202
Brand
baixin
Company
Anhui Kangda Medical Products Co.,Ltd.
Model
27GDN
Published
2025-05-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DZMNeedle, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZMNeedle, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06936018502226PackageGS15000Not in Commercial Distribution
06936018502219PrimaryGS10
06936018502202Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06936018502226069360185022266936018502226
06936018502219069360185022196936018502219
06936018502202069360185022026936018502202

GMDN Terms#

Term, Definition table
TermDefinition
Dental syringe needle, single-useA sterile, sharp bevel-edged, hollow tubular metal instrument with an integral hub, typically intended to be attached to a dental cartridge syringe for the injection of local anaesthetics. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
529827552
Device count
100
DM exempt
false
Premarket exempt
true
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
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06936018502424baixinKD2222025-11-19
06936018502219baixin27GDN2025-05-28
06936018502240baixin30GDN2025-05-28
06936018502257baixin30GDN2025-05-28
06936018501618BAIXIN18GSVS2024-03-04
06936018501649BAIXIN19GSVS2024-03-04
06936018501670BAIXIN20GSVS2024-03-04
06936018501700BAIXIN21GSVS2024-03-04
06936018501731BAIXIN22GSVS2024-03-04
06936018501762BAIXIN23GSVS2024-03-04
06936018501793BAIXIN24GSVS2024-03-04
06936018501823BAIXIN25GSVS2024-03-04
06936018501854BAIXIN26GSVS2024-03-04
06936018501885BAIXIN27GSVS2024-03-04
06936018501625BAIXIN18GSVS2024-03-04
06936018501656BAIXIN19GSVS2024-03-04
06936018501687BAIXIN20GSVS2024-03-04
06936018501717BAIXIN21GSVS2024-03-04
06936018501748BAIXIN22GSVS2024-03-04
06936018501779BAIXIN23GSVS2024-03-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06973042242766Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.DZM2026-07-09
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