FDA.report

Posterior Direct Bond Bracket Holder

Primary DI
00190707102371
Brand
Posterior Direct Bond Bracket Holder
Company
ORTHO ORGANIZERS, INC.
Model
200-311
Device description
Posterior Direct Bond Bracket Holder
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
ECQALIGNER, BRACKET, ORTHODONTIC

Product Code Classifications

CodeDeviceSpecialtyClass
ECQAligner, Bracket, OrthodonticDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00190707102371PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00190707102371001907071023711907071023710190707102371

GMDN Terms

TermDefinition
Orthodontic pliersA hand-held manual dental instrument designed to hold small objects or to bend or to cut metal strips or wire used in orthodontic procedures. It is typically made of high-grade steel and consists of two arms/rods that form a handle proximally and extend distally through a pivot point to terminate with jaws available in various shapes depending on intended use. 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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