FDA.reportPublic FDA data

PROCLINIC

Primary DI
20190886228514
Brand
PROCLINIC
Company
G & H Wire Company, Inc.
Model
L8188
Device description
ELASTIC INTRA 5/16 MED LUNA 4,5OZ
Published
2025-03-26
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
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ECIBand, elastic, orthodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ECIBand, Elastic, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20190886228514PackageGS150In Commercial Distribution
10190886228517PrimaryGS10
00190886228510Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2019088622851420190886228514
1019088622851710190886228517
00190886228510001908862285101908862285100190886228510

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic inter-arch elastic bandA non-sterile circular band intended to be used during orthodontic treatment to exert a continuous light force to adjust bite and jaw position for correcting malocclusions (e.g., overbite, underbite). It is made of an elastomeric material (e.g., polyurethane, rubber) and is secured to hooks on orthodontic brackets across non-opposing mandibular and maxillary teeth. This is a single-patient device intended to be replaced regularly during orthodontic treatment (single-use).

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
831465641
Device count
100
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190886271028G&H ORTHODONTICS ®130-U1-8R-V2026-02-27
00190886271035G&H ORTHODONTICS ®130-U1-8L-V2026-02-27
00190886271042G&H ORTHODONTICS ®130-U2-8R-V2026-02-27
00190886271059G&H ORTHODONTICS ®130-U2-8L-V2026-02-27
00190886271066G&H ORTHODONTICS ®130-U3-8RK-V2026-02-27
00190886271073G&H ORTHODONTICS ®130-U3-8LK-V2026-02-27
00190886271080G&H ORTHODONTICS ®130-U4-8RK-V2026-02-27
00190886271097G&H ORTHODONTICS ®130-U4-8LK-V2026-02-27
00190886271103G&H ORTHODONTICS ®130-U4-8U-V2026-02-27
00190886271110G&H ORTHODONTICS ®130-L1-8U-V2026-02-27
00190886271127G&H ORTHODONTICS ®130-L3-8RK-V2026-02-27
00190886271134G&H ORTHODONTICS ®130-L3-8LK-V2026-02-27
00190886271141G&H ORTHODONTICS ®130-L4-8U-V2026-02-27
00190886271158G&H ORTHODONTICS ®130-L4-8RK-V2026-02-27
00190886271165G&H ORTHODONTICS ®130-L4-8LK-V2026-02-27
00190886271172G&H ORTHODONTICS ®130-L5-8U-V2026-02-27
00190886271189G&H ORTHODONTICS ®130-L5-8RK-V2026-02-27
00190886271196G&H ORTHODONTICS ®130-L5-8LK-V2026-02-27
10190886271209G&H ORTHODONTICS ®130K-345-18-012026-02-27
10190886271216G&H ORTHODONTICS ®130K-3-18-012026-02-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00371347021028Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021035Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021042Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021059Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021066Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021073Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021080Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021097Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021103Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021110Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021127Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021134Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021141Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021158Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021165Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021172Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021189Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021196Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021202Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021219Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021226Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021233Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021240Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021257Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021264Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021271Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021288Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021295Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021301Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021318Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15