FDA.reportPublic FDA data

AGILITY

Primary DI
10190886052976
Brand
AGILITY
Company
G & H Wire Company, Inc.
Model
AC1-218-X
Device description
AGILITY BT-UL .022 WD COMB CONV MBT -14°T 10°DO .045
Published
2025-03-27
Public version status
New
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
DZDTUBE, ORTHODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZDTube, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10190886052976PrimaryGS10
00190886052979Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1019088605297610190886052976
00190886052979001908860529791908860529790190886052979

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic tubeA device used in orthodontics to attach a wire(s) or headgear to orthodontic bands bonded to the teeth. It is typically welded to an orthodontic band or bonded to a tooth. This is a single-patient device that is used for the duration of the treatment (single-use) before being discarded.

Contacts#

Phone, Email table
PhoneEmail
+1(317)346-6655orders@ghortho.com

Regulatory Flags#

DUNS number
831465641
Device count
10
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10190886271612G&H ORTHODONTICS ®131-L5-8RK-V2026-02-27
10190886271629G&H ORTHODONTICS ®131-L5-8LK-V2026-02-27
10190886271841G&H ORTHODONTICS ®131-L5-2RK-V2026-02-27
10190886271858G&H ORTHODONTICS ®131-L5-2LK-V2026-02-27
10190886271025G&H ORTHODONTICS ®130-U1-8R-V2026-02-27
10190886271032G&H ORTHODONTICS ®130-U1-8L-V2026-02-27
10190886271049G&H ORTHODONTICS ®130-U2-8R-V2026-02-27
10190886271056G&H ORTHODONTICS ®130-U2-8L-V2026-02-27
10190886271063G&H ORTHODONTICS ®130-U3-8RK-V2026-02-27
10190886271070G&H ORTHODONTICS ®130-U3-8LK-V2026-02-27
10190886271087G&H ORTHODONTICS ®130-U4-8RK-V2026-02-27
10190886271094G&H ORTHODONTICS ®130-U4-8LK-V2026-02-27
10190886271100G&H ORTHODONTICS ®130-U4-8U-V2026-02-27
10190886271117G&H ORTHODONTICS ®130-L1-8U-V2026-02-27
10190886271124G&H ORTHODONTICS ®130-L3-8RK-V2026-02-27
10190886271131G&H ORTHODONTICS ®130-L3-8LK-V2026-02-27
10190886271148G&H ORTHODONTICS ®130-L4-8U-V2026-02-27
10190886271155G&H ORTHODONTICS ®130-L4-8RK-V2026-02-27
10190886271162G&H ORTHODONTICS ®130-L4-8LK-V2026-02-27
10190886271179G&H ORTHODONTICS ®130-L5-8U-V2026-02-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840456203514JMUJMU DENTAL, INCDZD2026-06-25
00840456203521JMUJMU DENTAL, INCDZD2026-06-25
00840456203538JMUJMU DENTAL, INCDZD2026-06-25
00840456203545JMUJMU DENTAL, INCDZD2026-06-25
00840456203552JMUJMU DENTAL, INCDZD2026-06-25
00840456205297JMUJMU DENTAL, INCDZD2026-06-25
00840456205303JMUJMU DENTAL, INCDZD2026-06-25
00840456205310JMUJMU DENTAL, INCDZD2026-06-25
00840456205327JMUJMU DENTAL, INCDZD2026-06-25
00840456205334JMUJMU DENTAL, INCDZD2026-06-25
00840456205341JMUJMU DENTAL, INCDZD2026-06-25
00840456205358JMUJMU DENTAL, INCDZD2026-06-25
00840456205365JMUJMU DENTAL, INCDZD2026-06-25
00840456205372JMUJMU DENTAL, INCDZD2026-06-25
00840456206034JMUJMU DENTAL, INCDZD2026-06-25
00840456206041JMUJMU DENTAL, INCDZD2026-06-25
00840456206058JMUJMU DENTAL, INCDZD2026-06-25
00840456206089JMUJMU DENTAL, INCDZD2026-06-25
00840456206096JMUJMU DENTAL, INCDZD2026-06-25
00840456206102JMUJMU DENTAL, INCDZD2026-06-25
00840456206119JMUJMU DENTAL, INCDZD2026-06-25
00840456206126JMUJMU DENTAL, INCDZD2026-06-25
00840456206133JMUJMU DENTAL, INCDZD2026-06-25
00840456206140JMUJMU DENTAL, INCDZD2026-06-25
00840456206157JMUJMU DENTAL, INCDZD2026-06-25
00840456206164JMUJMU DENTAL, INCDZD2026-06-25
00840456206171JMUJMU DENTAL, INCDZD2026-06-25
00840456206188JMUJMU DENTAL, INCDZD2026-06-25
00840456206195JMUJMU DENTAL, INCDZD2026-06-25
00840456206201JMUJMU DENTAL, INCDZD2026-06-25