DEVICE: SPEED Tubular Supercable Kit (75402950800022)

Device Identifier (DI) Information

SPEED Tubular Supercable Kit
75402950800022
Not in Commercial Distribution

Hespeler Orthodontics Limited
75402950800022
GS1
August 09, 2024
1
203297635 *Terms of Use
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
Yes
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GMDN

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GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
41397 Orthodontic archwire
A dental wire in the shape of an arch used with orthodontic attachments (orthodontic brackets) that are affixed to the crowns/surfaces of two or more teeth in order to cause/guide tooth movement. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded.
Active false
33209 Orthodontic pliers
A hand-held manual dental instrument designed to hold small objects or to bend or to cut metal strips or wire used in orthodontic procedures. It is typically made of high-grade steel and consists of two arms/rods that form a handle proximally and extend distally through a pivot point to terminate with jaws available in various shapes depending on intended use. This is a reusable device.
Active false
31799 Orthodontic appliance dimension gauge
A dental instrument intended to be used for accurate measurement of the dimensions of an orthodontic appliance (e.g., orthodontic bracket height) especially as it relates to patient oral anatomy during the fitting of the appliance (e.g., determining distance from the incisal edge to an orthodontic bracket locator blade). This is a reusable device.
Active false
65562 Orthodontic archwire protection sleeve
A 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.
Active false
38741 Orthodontic lock
A dental device intended to be placed on an orthodontic archwire or rod via screwing, crimping, or soldering, for orthodontic spring activation and/or to prevent the archwire from sliding within the brackets. It may be designed in various forms (e.g., Gurin lock, stop). It does not incorporate a pin or hook. This is a single-patient device that is used for the duration of the treatment (single-use) before being discarded.
Active false
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FDA Product Code

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Product Code Product Code Name
No Product Codes
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

40ff9e5a-7558-4e9f-8f08-eba0419f9520
August 12, 2024
2
November 10, 2022
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
No
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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