FDA.reportPublic FDA data

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

Primary DI
86973329322910
Brand
Tonia Tube,1st M.,.022 Roth,Bond,Sgl,N-Cov,LR
Company
Astar Orthodontics Inc.
Model
3112-4411
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

Product Codes#

Code, Name table
CodeName
DZDTube, Orthodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZDTube, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06973329322914PrimaryGS10
86973329322910Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06973329322914069733293229146973329322914
8697332932291086973329322910

GMDN Terms#

Term, Definition table
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 table
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06941673501453Thino Roth Bracket, .022, Mini Size, UL11212-0112023-12-31
06941673501460Thino Roth Bracket, .022, Mini Size, UL21212-0122023-12-31
06941673501477Thino Roth Bracket, .022 Mini, UL3, w/hk at distal1212-013Hd2023-12-31
06941673501484Thino Roth Bracket, .022 Mini, UL4, w/o hook1212-0142023-12-31
06941673501491Thino Roth Bracket, .022 Mini, UL4, w/hk at mesial1212-014Hm2023-12-31
06941673501507Thino Roth Bracket, .022 Mini, UL4, w/hk at distal1212-014Hd2023-12-31
06941673501514Thino Roth Bracket, .022 Mini, UL5, w/o hook1212-0152023-12-31
06941673501521Thino Roth Bracket, .022 Mini, UL5, w/hk at mesial1212-015Hm2023-12-31
06941673501538Thino Roth Bracket, .022 Mini, UL5, w/hk at distal1212-015Hd2023-12-31
06941673501545Thino Roth Bracket, .022, Mini Size, UR11212-0212023-12-31
06941673501552Thino Roth Bracket, .022, Mini Size, UR21212-0222023-12-31
06941673501576Thino Roth Bracket, .022 Mini, UR4, w/o hook1212-0242023-12-31
06941673501583Thino Roth Bracket, .022 Mini, UR4, w/hk at mesial1212-024Hm2023-12-31
06941673501590Thino Roth Bracket, .022 Mini, UR4, w/hk at distal1212-024Hd2023-12-31
06941673501606Thino Roth Bracket, .022 Mini, UR4, w/hk at distal1212-0252023-12-31
06941673501613Thino Roth Bracket, .022 Mini, UR5, w/hk at mesial1212-025Hm2023-12-31
06941673501620Thino Roth Bracket, .022 Mini, UR5, w/hk at distal1212-025Hd2023-12-31
06941673501637Thino Roth Bracket, .022, Mini Size, LL11212-0312023-12-31
06941673501644Thino Roth Bracket, .022, Mini Size, LL21212-0322023-12-31
06941673501651Thino Roth Bracket, .022 Mini, LL3, w/hk at distal1212-033Hd2023-12-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840456203514JMUJMU DENTAL, INCDZD2026-06-25
00840456203521JMUJMU DENTAL, INCDZD2026-06-25
00840456203538JMUJMU DENTAL, INCDZD2026-06-25
00840456203545JMUJMU DENTAL, INCDZD2026-06-25
00840456203552JMUJMU DENTAL, INCDZD2026-06-25
00840456205297JMUJMU DENTAL, INCDZD2026-06-25
00840456205303JMUJMU DENTAL, INCDZD2026-06-25
00840456205310JMUJMU DENTAL, INCDZD2026-06-25
00840456205327JMUJMU DENTAL, INCDZD2026-06-25
00840456205334JMUJMU DENTAL, INCDZD2026-06-25
00840456205341JMUJMU DENTAL, INCDZD2026-06-25
00840456205358JMUJMU DENTAL, INCDZD2026-06-25
00840456205365JMUJMU DENTAL, INCDZD2026-06-25
00840456205372JMUJMU DENTAL, INCDZD2026-06-25
00840456206034JMUJMU DENTAL, INCDZD2026-06-25
00840456206041JMUJMU DENTAL, INCDZD2026-06-25
00840456206058JMUJMU DENTAL, INCDZD2026-06-25
00840456206089JMUJMU DENTAL, INCDZD2026-06-25
00840456206096JMUJMU DENTAL, INCDZD2026-06-25
00840456206102JMUJMU DENTAL, INCDZD2026-06-25
00840456206119JMUJMU DENTAL, INCDZD2026-06-25
00840456206126JMUJMU DENTAL, INCDZD2026-06-25
00840456206133JMUJMU DENTAL, INCDZD2026-06-25
00840456206140JMUJMU DENTAL, INCDZD2026-06-25
00840456206157JMUJMU DENTAL, INCDZD2026-06-25
00840456206164JMUJMU DENTAL, INCDZD2026-06-25
00840456206171JMUJMU DENTAL, INCDZD2026-06-25
00840456206188JMUJMU DENTAL, INCDZD2026-06-25
00840456206195JMUJMU DENTAL, INCDZD2026-06-25
00840456206201JMUJMU DENTAL, INCDZD2026-06-25