FDA.report

PROCLINIC

Primary DI
00190886229630
Brand
PROCLINIC
Company
G & H Wire Company, Inc.
Model
L8162
Device description
BARRA LIGADURAS ELAST .120 FOSF VERDE
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

Related Records

Contact Domains

Product Codes

CodeName
ECIBand, elastic, orthodontic

Product Code Classifications

CodeDeviceSpecialtyClass
ECIBand, Elastic, OrthodonticDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10190886229637PrimaryGS10
00190886229630Unit of UseGS10

Alternate GTIN/UPC/EAN values are derived from GS1 digit structure for lookup convenience. Do not treat derived UPC-A or EAN-13 values as separate FDA identifiers. GTIN-14 values with indicator digits 1-9 usually represent packaging levels, cases, pallets, or variable-measure items and are not converted to UPC-A/EAN-13 here.

Alternate GTIN / UPC / EAN Codes

Source identifierSource lengthGTIN-14 normalizedIndicatorUPC-AEAN-13Conversion note
1019088622963714101908862296371Indicator 1 usually represents packaging or variable measure; UPC/EAN conversion is not shown.
00190886229630140019088622963001908862296300190886229630Indicator 0 and prefix 00 allow UPC-A and EAN-13 conversion.

GMDN Terms

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).

Sterilization Methods

Method

Contacts

PhoneEmail
+1(317)346-6655orders@ghortho.com

Regulatory Flags

DUNS number
831465641
Device count
46
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
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

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

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