FDA.reportPublic FDA data

N/A

Primary DI
10195291009171
Brand
N/A
Company
Flexmedics
Model
SOF-HPR
Device description
SG HI PULL HEADCAP REG.
Published
2020-05-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DZBHeadgear, Extraoral, Orthodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZBHeadgear, Extraoral, OrthodonticDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K111169000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K111169000PROTRACTION FACE MASK, REVERSE PULL FACE MASK MODEL KM-PVS, KM-PIS, KM-PVM, KM-PIM, MODEL KM-FMS, KM-FML, KM-FMFKwang Myung Daicom, Inc.2011-10-03DZB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10195291009171PrimaryGS10
00195291009174Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1019529100917110195291009171
00195291009174001952910091741952910091740195291009174

GMDN Terms#

Term, Definition table
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).

Contacts#

Phone, Email table
PhoneEmail
317-346-6655ORDERS@GHORTHO.COM

Regulatory Flags#

DUNS number
028853567
Device count
5
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10195291000017N/A125-L1-2U-V2020-05-27
10195291000024N/A125-L1-8U-V2020-05-27
10195291000031N/A125-L3-2LK-V2020-05-26
10195291000048N/A125-L3-2RK-V2020-05-26
10195291000055N/A125-L3-8LK-V2020-05-26
10195291000062N/A125-L3-8RK-V2020-05-26
10195291000079N/A125-L4-2LK-V2020-05-26
10195291000086N/A125-L4-2RK-V2020-05-26
10195291000093N/A125-L4-8LK-V2020-05-26
10195291000109N/A125-L4-8RK-V2020-05-26
10195291000116N/A125-L5-2LK-V2020-05-26
10195291000123N/A125-L5-2RK-V2020-05-26
10195291000130N/A125-L5-8LK-V2020-05-26
10195291000147N/A125-L5-8RK-V2020-05-26
10195291000154N/A125-U1-2L-V2020-05-26
10195291000161N/A125-U1-2R-V2020-05-26
10195291000178N/A125-U1-8L-V2020-05-26
10195291000185N/A125-U1-8R-V2020-05-26
10195291000192N/A125-U2-2L-V2020-05-26
10195291000208N/A125-U2-2R-V2020-05-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10190886051818NAG & H Wire Company, Inc.DZB2025-03-31
10190886051825NAG & H Wire Company, Inc.DZB2025-03-31
10190886051832NAG & H Wire Company, Inc.DZB2025-03-31
10190886051849NAG & H Wire Company, Inc.DZB2025-03-31
10190886051856NAG & H Wire Company, Inc.DZB2025-03-31
10190886051863NAG & H Wire Company, Inc.DZB2025-03-31
10190886051870NAG & H Wire Company, Inc.DZB2025-03-31
10190886051887NAG & H Wire Company, Inc.DZB2025-03-31
10190886051894NAG & H Wire Company, Inc.DZB2025-03-31
10190886051900NAG & H Wire Company, Inc.DZB2025-03-31
10190886051917NAG & H Wire Company, Inc.DZB2025-03-31
10190886051924NAG & H Wire Company, Inc.DZB2025-03-31
10190886051931NAG & H Wire Company, Inc.DZB2025-03-31
10190886051948NAG & H Wire Company, Inc.DZB2025-03-31
10190886052020NAG & H Wire Company, Inc.DZB2025-03-31
10190886052037NAG & H Wire Company, Inc.DZB2025-03-31
10190886052044NAG & H Wire Company, Inc.DZB2025-03-31
10190886052051NAG & H Wire Company, Inc.DZB2025-03-31
10190886052068NAG & H Wire Company, Inc.DZB2025-03-31
10190886052075NAG & H Wire Company, Inc.DZB2025-03-31
10190886155226NAG & H Wire Company, Inc.DZB2025-03-31
10190886155233NAG & H Wire Company, Inc.DZB2025-03-31
10190886155240NAG & H Wire Company, Inc.DZB2025-03-31
10190886155257NAG & H Wire Company, Inc.DZB2025-03-31
10190886155264NAG & H Wire Company, Inc.DZB2025-03-31
10195291008266N/AFlexmedicsDZB2020-05-26
10195291009133N/AFlexmedicsDZB2020-05-26
10195291009140N/AFlexmedicsDZB2020-05-26
10195291009157N/AFlexmedicsDZB2020-05-26
10195291009164N/AFlexmedicsDZB2020-05-26