FDA.reportPublic FDA data

PROCLINIC

Primary DI
10190886229224
Brand
PROCLINIC
Company
G & H Wire Company, Inc.
Model
L6283
Device description
"LIGADURAS METALICAS LARGAS .009"""
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
DZCWIRE, ORTHODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZCWire, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10190886229224PrimaryGS10
00190886229227Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1019088622922410190886229224
00190886229227001908862292271908862292270190886229227

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic archwire/bracket ligatureA device intended to securely tether an orthodontic archwire to an orthodontic bracket, or securely hold the archwire in the archwire slot of an orthodontic bracket (or brace). It is in the form of a small single tie, or a circular band made of elastomeric (e.g., polyurethane, rubber) or metal materials. This is a single-patient device intended to be replaced regularly during orthodontic treatment (single-use).

Contacts#

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

Regulatory Flags#

DUNS number
831465641
Device count
1000
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
00840456209882JMUJMU DENTAL, INCDZC2026-06-25
00840456209899JMUJMU DENTAL, INCDZC2026-06-25
00840456209905JMUJMU DENTAL, INCDZC2026-06-25
00840456209912JMUJMU DENTAL, INCDZC2026-06-25
00840456209929JMUJMU DENTAL, INCDZC2026-06-25
00840456209936JMUJMU DENTAL, INCDZC2026-06-25
00840456209943JMUJMU DENTAL, INCDZC2026-06-25
00840456209950JMUJMU DENTAL, INCDZC2026-06-25
00840456209967JMUJMU DENTAL, INCDZC2026-06-25
00840456209974JMUJMU DENTAL, INCDZC2026-06-25
00840456209981JMUJMU DENTAL, INCDZC2026-06-25
00840456209998JMUJMU DENTAL, INCDZC2026-06-25
00840456210000JMUJMU DENTAL, INCDZC2026-06-25
00840456210017JMUJMU DENTAL, INCDZC2026-06-25
00840456210024JMUJMU DENTAL, INCDZC2026-06-25
00840456210031JMUJMU DENTAL, INCDZC2026-06-25
00840456210048JMUJMU DENTAL, INCDZC2026-06-25
00840456210055JMUJMU DENTAL, INCDZC2026-06-25
00840456210062JMUJMU DENTAL, INCDZC2026-06-25
00840456210079JMUJMU DENTAL, INCDZC2026-06-25
00840456210086JMUJMU DENTAL, INCDZC2026-06-25
00840456210093JMUJMU DENTAL, INCDZC2026-06-25
00840456210109JMUJMU DENTAL, INCDZC2026-06-25
00840456210116JMUJMU DENTAL, INCDZC2026-06-25
00840456210123JMUJMU DENTAL, INCDZC2026-06-25
00840456210130JMUJMU DENTAL, INCDZC2026-06-25
00840456211182JMUJMU DENTAL, INCDZC2026-06-25
00840456211199JMUJMU DENTAL, INCDZC2026-06-25
00840456211205JMUJMU DENTAL, INCDZC2026-06-25
00840456211212JMUJMU DENTAL, INCDZC2026-06-25