FDA.report

NA

Primary DI
00190886128759
Brand
NA
Company
G & H Wire Company, Inc.
Model
CS1B-805I-X
Device description
BT-UR .018 DB SGL CONV ROTH -10°T 8°DO W/IN BASE 10PK
Published
2025-03-27
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

Product Codes

CodeName
DZDTUBE, ORTHODONTIC

Product Code Classifications

CodeDeviceSpecialtyClass
DZDTube, OrthodonticDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10190886128756PrimaryGS10
00190886128759Unit of UseGS10

GMDN Terms

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.

Sterilization Methods

Method

Contacts

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

Regulatory Flags

DUNS number
831465641
Device count
10
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
false
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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00190746197130Empower TubeAMERICAN ORTHODONTICS CORPORATIONDZD2026-03-23
00190746197147Empower TubeAMERICAN ORTHODONTICS CORPORATIONDZD2026-03-23
00190746197154Empower TubeAMERICAN ORTHODONTICS CORPORATIONDZD2026-03-23
00190746197161Empower TubeAMERICAN ORTHODONTICS CORPORATIONDZD2026-03-23
00190746197178Empower TubeAMERICAN ORTHODONTICS CORPORATIONDZD2026-03-23
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00190746197239Empower TubeAMERICAN ORTHODONTICS CORPORATIONDZD2026-03-23
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00190746197253Empower TubeAMERICAN ORTHODONTICS CORPORATIONDZD2026-03-23
00190746197260Empower TubeAMERICAN ORTHODONTICS CORPORATIONDZD2026-03-23
00190746197277Empower TubeAMERICAN ORTHODONTICS CORPORATIONDZD2026-03-23
00190746197284Empower TubeAMERICAN ORTHODONTICS CORPORATIONDZD2026-03-23
00190746197291Empower TubeAMERICAN ORTHODONTICS CORPORATIONDZD2026-03-23
00190746197307Empower TubeAMERICAN ORTHODONTICS CORPORATIONDZD2026-03-23
00190746197314Empower TubeAMERICAN ORTHODONTICS CORPORATIONDZD2026-03-23
00190746197321Empower TubeAMERICAN ORTHODONTICS CORPORATIONDZD2026-03-23
00190746197338Empower TubeAMERICAN ORTHODONTICS CORPORATIONDZD2026-03-23
00190746197345Empower TubeAMERICAN ORTHODONTICS CORPORATIONDZD2026-03-23
00190746197352Empower TubeAMERICAN ORTHODONTICS CORPORATIONDZD2026-03-23
00190746197369Empower TubeAMERICAN ORTHODONTICS CORPORATIONDZD2026-03-23
00190746197376Empower TubeAMERICAN ORTHODONTICS CORPORATIONDZD2026-03-23
00190746197383Empower TubeAMERICAN ORTHODONTICS CORPORATIONDZD2026-03-23
00190746197390Empower TubeAMERICAN ORTHODONTICS CORPORATIONDZD2026-03-23
00190746197406Empower TubeAMERICAN ORTHODONTICS CORPORATIONDZD2026-03-23