FDA.report

Tonia Tube,1st M.,.022 Roth,Bond,Sgl,N-Cov,LL

Primary DI
86973329322903
Brand
Tonia Tube,1st M.,.022 Roth,Bond,Sgl,N-Cov,LL
Company
Astar Orthodontics Inc.
Model
3112-4311
Published
2023-12-31
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
06973329322907PrimaryGS10
86973329322903Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
06973329322907069733293229076973329322907
8697332932290386973329322903

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
547794613
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
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
86941673501459Thino Roth Bracket, .022, Mini Size, UL11212-0112023-12-31
86941673501466Thino Roth Bracket, .022, Mini Size, UL21212-0122023-12-31
86941673501473Thino Roth Bracket, .022 Mini, UL3, w/hk at distal1212-013Hd2023-12-31
86941673501480Thino Roth Bracket, .022 Mini, UL4, w/o hook1212-0142023-12-31
86941673501497Thino Roth Bracket, .022 Mini, UL4, w/hk at mesial1212-014Hm2023-12-31
86941673501503Thino Roth Bracket, .022 Mini, UL4, w/hk at distal1212-014Hd2023-12-31
86941673501510Thino Roth Bracket, .022 Mini, UL5, w/o hook1212-0152023-12-31
86941673501527Thino Roth Bracket, .022 Mini, UL5, w/hk at mesial1212-015Hm2023-12-31
86941673501534Thino Roth Bracket, .022 Mini, UL5, w/hk at distal1212-015Hd2023-12-31
86941673501541Thino Roth Bracket, .022, Mini Size, UR11212-0212023-12-31
86941673501558Thino Roth Bracket, .022, Mini Size, UR21212-0222023-12-31
06941673501569Thino Roth Bracket, .022 Mini, UR3, w/hk at distal1212-023Hd2023-12-31
86941673501572Thino Roth Bracket, .022 Mini, UR4, w/o hook1212-0242023-12-31
86941673501589Thino Roth Bracket, .022 Mini, UR4, w/hk at mesial1212-024Hm2023-12-31
86941673501596Thino Roth Bracket, .022 Mini, UR4, w/hk at distal1212-024Hd2023-12-31
86941673501602Thino Roth Bracket, .022 Mini, UR4, w/hk at distal1212-0252023-12-31
86941673501619Thino Roth Bracket, .022 Mini, UR5, w/hk at mesial1212-025Hm2023-12-31
86941673501626Thino Roth Bracket, .022 Mini, UR5, w/hk at distal1212-025Hd2023-12-31
86941673501633Thino Roth Bracket, .022, Mini Size, LL11212-0312023-12-31
86941673501640Thino Roth Bracket, .022, Mini Size, LL21212-0322023-12-31

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