FDA.reportPublic FDA data

SPEED Reinforcing Tube

Primary DI
07540295000321
Brand
SPEED Reinforcing Tube
Company
Hespeler Orthodontics Limited
Model
07540295000321
Published
2024-08-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
75402950600028PreviousGS10
07540295000321PrimaryGS10
07540295900218Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
7540295060002875402950600028
07540295000321075402950003217540295000321
07540295900218075402959002187540295900218

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic archwire protection sleeveA small, hollow tube/cylinder intended to be cut to a selected length and placed around an orthodontic archwire to protect the archwire from damage and to protect teeth, gums, and cheeks from archwire exposure during orthodontic treatment. This is a single-use device.

Regulatory Flags#

DUNS number
203297635
Device count
10
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07540295000017SPEED Bracket075402950000172024-08-09
07540295000024SPEED Bracket075402950000242024-08-09
07540295000031SPEED Bracket075402950000312024-08-09
07540295000048SPEED Buccal Tube075402950000482024-08-09
07540295000055SPEED Buccal Tube075402950000552024-08-09
07540295000062SPEED Buccal Tube075402950000622024-08-09
07540295000079SPEED Buccal Tube Samples075402950000792024-08-09
07540295000086SPEED Convertible Buccal Tube075402950000862024-08-09
07540295000093SPEED Convertible Buccal Tube075402950000932024-08-09
07540295000109SPEED Convertible Buccal Tube075402950001092024-08-09
07540295000116SPEED Beta Titanium Archwire075402950001162024-08-09
07540295000123SPEED Coaxial Archwire075402950001232024-08-09
07540295000130SPEED D-Wire - Nickel Titanium075402950001302024-08-09
07540295000147SPEED D-Wire - Stainless Steel075402950001472024-08-09
07540295000154Hills Dual-Geometry Wire075402950001542024-08-09
07540295000161Round Nickel Titanium Archwire075402950001612024-08-09
07540295000178SPEED Wire - Nickel Titanium075402950001782024-08-09
07540295000185SPEED Wire - Stainless Steel075402950001852024-08-09
07540295000192SPEED Supercable075402950001922024-08-09
07540295000208SPEED Lingual Supercable075402950002082024-08-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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