FDA.report

SBC-M18-261G

Primary DI
08800046028356
Brand
SBC-M18-261G
Company
GNI Co.,Ltd
Model
SBC-M18-261G
Published
2023-02-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
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
08800046028356PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08800046028356088000460283568800046028356

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

Regulatory Flags

DUNS number
694828541
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
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
08800046051484SS650SS6502025-04-04
08800046051309SSBC-M22-464GSSBC-M22-464G2024-06-18
08800046051316SSBC-M22-364GSSBC-M22-364G2024-06-18
08800046051323SSBC-M22-264GSSBC-M22-264G2024-06-18
08800046051330SSBC-M22-164GSSBC-M22-164G2024-06-18
08800046051385SSBC-M22-1M44GSSBC-M22-1M44G2024-06-18
08800046027540IES1-1001IES1-10012024-06-04
08800046045896P01-01P01-012024-06-04
08800046046602SN02-1018SN02-10182024-06-04
08800046050357ELT-01ELT-012024-06-04
08800046000642SA1208CSA1208C2022-12-13
08800046000659SA1210CSA1210C2022-12-13
08800046000666SA1406CSA1406C2022-12-13
08800046000673SA1408CSA1408C2022-12-13
08800046000680SA1410CSA1410C2022-12-13
08800046000697SA1606CSA1606C2022-12-13
08800046000703SA1608CSA1608C2022-12-13
08800046000710SA1610CSA1610C2022-12-13
08800046000727SA1806CSA1806C2022-12-13
08800046000734SA1808CSA1808C2022-12-13

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00190746197116Empower TubeAMERICAN ORTHODONTICS CORPORATIONDZD2026-03-23
00190746197123Empower TubeAMERICAN ORTHODONTICS CORPORATIONDZD2026-03-23
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
00190746197185Empower TubeAMERICAN ORTHODONTICS CORPORATIONDZD2026-03-23
00190746197192Empower TubeAMERICAN ORTHODONTICS CORPORATIONDZD2026-03-23
00190746197208Empower TubeAMERICAN ORTHODONTICS CORPORATIONDZD2026-03-23
00190746197215Empower TubeAMERICAN ORTHODONTICS CORPORATIONDZD2026-03-23
00190746197222Empower TubeAMERICAN ORTHODONTICS CORPORATIONDZD2026-03-23
00190746197239Empower TubeAMERICAN ORTHODONTICS CORPORATIONDZD2026-03-23
00190746197246Empower TubeAMERICAN ORTHODONTICS CORPORATIONDZD2026-03-23
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