FDA.report

Multi-Adjustable Facemask

Primary DI
00190730002563
Brand
Multi-Adjustable Facemask
Company
ORTHO TECHNOLOGY, INC.
Model
550-400D
Device description
DLR-Multi-Adjust Facemask Blu
Published
2016-09-24
Public version status
Update
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
DZBHeadgear, extraoral, orthodontic

Product Code Classifications

CodeDeviceSpecialtyClass
DZBHeadgear, Extraoral, OrthodonticDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00190730002563PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00190730002563001907300025631907300025630190730002563

GMDN Terms

TermDefinition
Orthodontic extraoral headgearA dental device used in conjunction with orthodontic appliances to exert pressure on the teeth or the jaws from outside the mouth. An orthodontic headgear will typically have a strap that wraps around the patient's neck or head and an inner bow portion that is fastened to the orthodontic appliance in the patient's mouth, or utilizes rests on the chin and forehead (reverse pull headgear).

Sterilization Methods

Method

Regulatory Flags

DUNS number
781772017
Device count
1
DM exempt
true
Premarket exempt
false
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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00190730084835Ortho TechnologyOT-2118-SSD2024-09-18
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00190730084439Ortho TechnologyOT-2092024-09-17
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