FDA.report

Henry Schein

Primary DI
10304040108397
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
1018359
Catalog number
1018359
Device description
Blu-Bite Ribbon Tips
Published
2019-09-09
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
EIDSYRINGE, RESTORATIVE AND IMPRESSION MATERIAL

Product Code Classifications

CodeDeviceSpecialtyClass
EIDSyringe, Restorative And Impression MaterialDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10304040108397PrimaryGS10
00304040108390Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1030404010839710304040108397
00304040108390003040401083903040401083900304040108390

GMDN Terms

TermDefinition
Dental impression material kit, reusableA collection of non-sterile devices designed to obtain a negative imprint of the teeth and/or upper palate (i.e., the roof of the mouth with the gums and teeth). It is subsequently used to make a mould for the manufacture of a custom-made dental prosthesis, orthodontic appliance, and/or oral appliance. The kit typically includes dental impression materials and reusable application devices (e.g., cartridge gun), and might include a dental impression tray(s). Impression material is placed on the tray and the tray is then positioned in the mouth of the patient until the material becomes firm creating the mould. This is a reusable device that may contain some disposable devices.

Sterilization Methods

Method

Regulatory Flags

DUNS number
012430880
Device count
24
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
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

Other Devices From This Company

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00304040187555Zirlux920005592000552026-02-04
00304040187562Zirlux920005692000562026-02-04
00304040187579Zirlux920005792000572026-02-04
00304040187586Zirlux920005892000582026-02-04
00304040187593Zirlux920005992000592026-02-04
00304040187616Zirlux920006192000612026-02-04
00304040187623Zirlux920006292000622026-02-04
00304040187647Zirlux920006392000632026-02-04
00304040187654Zirlux920006492000642026-02-04
00304040187661Zirlux920006592000652026-02-04

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