FDA.report

Henry Schein

Primary DI
10304040065331
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
1068726
Catalog number
1068726
Device description
MOLAR BAND LL 1ST 38.5 (2)
Published
2020-02-05
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
ECMBAND, PREFORMED, ORTHODONTIC

Product Code Classifications

CodeDeviceSpecialtyClass
ECMBand, Preformed, OrthodonticDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10304040065331PrimaryGS10
00304040065334Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1030404006533110304040065331
00304040065334003040400653343040400653340304040065334

GMDN Terms

TermDefinition
Orthodontic metal bandA thin metal ring designed to be fitted around the contours of a tooth and cemented into place to support an orthodontic attachment (e.g., bracket, tube), brazed or soldered onto the ring, intended to be secured to the tooth. 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
2
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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00304040187555Zirlux920005592000552026-02-04
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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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