FDA.report

Henry Schein

Primary DI
00304040128640
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
1008494
Catalog number
1008494
Device description
Discoid & Cleoid DE 3/6
Published
2020-03-06
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
false

Related Records

Product Codes

CodeName
EIKCARVER, WAX, DENTAL

Product Code Classifications

CodeDeviceSpecialtyClass
EIKCarver, Wax, DentalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00304040128640PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00304040128640003040401286403040401286400304040128640

GMDN Terms

TermDefinition
Dental wax carverA hand-held manual dental instrument used to carve wax patterns with a blunt blade of varying size and shape, which can be heated for softening the wax while fashioning the pattern. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
012430880
Device count
1
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
true

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

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