FDA.reportPublic FDA data

SPEED Reinforcing Tube

Primary DI
07540295900218
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
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
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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
203297635
Device count
10
DM exempt
true
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 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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