FDA.report

Schure Band Seater

Primary DI
00190707102869
Brand
Schure Band Seater
Company
ORTHO ORGANIZERS, INC.
Model
200-208
Device description
Schure Band Seater
Published
2022-10-17
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
false

Related Records

Product Codes

CodeName
ECSPUSHER, BAND, ORTHODONTIC

Product Code Classifications

CodeDeviceSpecialtyClass
ECSPusher, Band, OrthodonticDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00190707102869PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00190707102869001907071028691907071028690190707102869

GMDN Terms

TermDefinition
Orthodontic metal band pusherA hand-held dental instrument intended to be used by an orthodontist for positioning and adapting orthodontic metal bands on teeth. This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
062165188
Device count
1
DM exempt
true
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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