FDA.report

Henry Schein

Primary DI
20304040108752
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
5701400
Catalog number
5701400
Device description
Dentals syringe, 3cc Luer Lock Non sterile
Published
2019-10-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
EICSYRINGE, PERIODONTIC, ENDODONTIC, IRRIGATING

Product Code Classifications

CodeDeviceSpecialtyClass
EICSyringe, Periodontic, Endodontic, IrrigatingDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20304040108752PackageGS112In Commercial Distribution
10304040108755PrimaryGS10
00304040108758Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
2030404010875220304040108752
1030404010875510304040108755
00304040108758003040401087583040401087580304040108758

GMDN Terms

TermDefinition
Anaesthesia Luer syringe, non-sterileA non-sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used to administer (infuse) anaesthetic drugs. At the distal end of the barrel is a male Luer connector (typically a Luer-lock type) for the attachment of the female connector (hub) of a hypodermic needle, administration set or dental syringe cannula. It is typically made of plastic and silicone materials and may have anti-stick properties (internally precoated with compatible substances) that allow the plunger to move smoothly. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
012430880
Device count
100
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
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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00304040187616Zirlux920006192000612026-02-04
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00304040187647Zirlux920006392000632026-02-04
00304040187654Zirlux920006492000642026-02-04
00304040187661Zirlux920006592000652026-02-04

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