FDA.report

Henry Schein

Primary DI
00304040070574
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
1067072
Catalog number
1067072
Device description
SPLIT SURGICAL BALL HOOK .018
Published
2021-01-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
ECNCLAMP, WIRE, ORTHODONTIC

Product Code Classifications

CodeDeviceSpecialtyClass
ECNClamp, Wire, OrthodonticDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10304040070571PrimaryGS10
00304040070574Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1030404007057110304040070571
00304040070574003040400705743040400705740304040070574

GMDN Terms

TermDefinition
Orthodontic archwireA dental wire in the shape of an arch used with orthodontic attachments (orthodontic brackets) that are affixed to the crowns/surfaces of two or more teeth in order to cause/guide tooth movement. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded.

Sterilization Methods

Method

Regulatory Flags

DUNS number
012430880
Device count
10
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

Other Devices From This Company

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00304040187470Zirlux920004792000472026-02-04
00304040187487Zirlux920004892000482026-02-04
00304040187517Zirlux920005192000512026-02-04
00304040187524Zirlux920005292000522026-02-04
00304040187531Zirlux920005392000532026-02-04
00304040187548Zirlux920005492000542026-02-04
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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Primary DIBrandCompanyProduct codePublished
00840479201399EXTEND LINGUAL WIRESRELIANCE ORTHODONTIC PRODUCTS INCECN2026-03-05
00840479201405EXTEND MEASURING DEVICERELIANCE ORTHODONTIC PRODUCTS INCECN2026-03-05
00840479201412EXTEND LINGUAL WIRESRELIANCE ORTHODONTIC PRODUCTS INCECN2026-03-05
00840479201429EXTEND LINGUAL WIRESRELIANCE ORTHODONTIC PRODUCTS INCECN2026-03-05
00840479201436EXTEND LINGUAL WIRESRELIANCE ORTHODONTIC PRODUCTS INCECN2026-03-05
00840479201443EXTEND LINGUAL WIRESRELIANCE ORTHODONTIC PRODUCTS INCECN2026-03-05
00840479201450EXTEND LINGUAL WIRESRELIANCE ORTHODONTIC PRODUCTS INCECN2026-03-05
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