FDA.report

Henry Schein

Primary DI
00304040109342
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
1066248
Catalog number
1066248
Device description
INTRAORAL AMBER ELASTICS 3/16" 6 OZ X-HEAVY
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
ECIBAND, ELASTIC, ORTHODONTIC

Product Code Classifications

CodeDeviceSpecialtyClass
ECIBand, Elastic, OrthodonticDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10304040109349PrimaryGS10
00304040109342Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1030404010934910304040109349
00304040109342003040401093423040401093420304040109342

GMDN Terms

TermDefinition
Orthodontic inter-arch elastic bandA non-sterile circular band intended to be used during orthodontic treatment to exert a continuous light force to adjust bite and jaw position for correcting malocclusions (e.g., overbite, underbite). It is made of an elastomeric material (e.g., polyurethane, rubber) and is secured to hooks on orthodontic brackets across non-opposing mandibular and maxillary teeth. This is a single-patient device intended to be replaced regularly during orthodontic treatment (single-use).

Sterilization Methods

Method

Regulatory Flags

DUNS number
012430880
Device count
5000
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
true
Donation ID number
false
Contains natural rubber latex
true
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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