FDA.reportPublic FDA data

NA

Primary DI
10190886104347
Brand
NA
Company
G & H Wire Company, Inc.
Model
ROSP1000
Device description
RADIOPAQUE SEPARATORS
Published
2025-03-26
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
ECIBand, elastic, orthodontic

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10190886104347PrimaryGS10
00190886104340Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1019088610434710190886104347
00190886104340001908861043401908861043400190886104340

GMDN Terms#

Term, Definition table
TermDefinition
Dental wedge, single-useA small, dental device intended to be introduced between two adjacent teeth for slight separation during a dental procedure. It is typically used during the placement of a filling material, or to stabilize and support other devices (e.g., a matrix band and/or rubber dam). It may include a removable shield intended to protect the healthy tooth/teeth from damage by the instruments. This is a single-use device.

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
Expiration 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
00840456205020JMUJMU DENTAL, INCECI2026-06-22
00840456205037JMUJMU DENTAL, INCECI2026-06-22
00840456205044JMUJMU DENTAL, INCECI2026-06-22
00840456205051JMUJMU DENTAL, INCECI2026-06-22
00840456205068JMUJMU DENTAL, INCECI2026-06-22
00840456205075JMUJMU DENTAL, INCECI2026-06-22
00840456205082JMUJMU DENTAL, INCECI2026-06-22
00840456205099JMUJMU DENTAL, INCECI2026-06-22
00840456205105JMUJMU DENTAL, INCECI2026-06-22
00840456205112JMUJMU DENTAL, INCECI2026-06-22
00840456205129JMUJMU DENTAL, INCECI2026-06-22
00840456205136JMUJMU DENTAL, INCECI2026-06-22
00840456205143JMUJMU DENTAL, INCECI2026-06-22
00840456205150JMUJMU DENTAL, INCECI2026-06-22
00840456205167JMUJMU DENTAL, INCECI2026-06-22
00840456205174JMUJMU DENTAL, INCECI2026-06-22
00840456205181JMUJMU DENTAL, INCECI2026-06-22
00840456205198JMUJMU DENTAL, INCECI2026-06-22
00840456205204JMUJMU DENTAL, INCECI2026-06-22
00840456205211JMUJMU DENTAL, INCECI2026-06-22
00840456205228JMUJMU DENTAL, INCECI2026-06-22
00840456205235JMUJMU DENTAL, INCECI2026-06-22
00840456205242JMUJMU DENTAL, INCECI2026-06-22
00840456205259JMUJMU DENTAL, INCECI2026-06-22
00840456205426JMUJMU DENTAL, INCECI2026-06-22
00840456205433JMUJMU DENTAL, INCECI2026-06-22
00840456205440JMUJMU DENTAL, INCECI2026-06-22
00840456205457JMUJMU DENTAL, INCECI2026-06-22
00840456205464JMUJMU DENTAL, INCECI2026-06-22
00840456205471JMUJMU DENTAL, INCECI2026-06-22