Telescopes

GUDID J01854441

Telescopes HF 15, 1 pair

Scheu-Dental GmbH

Orthodontic power arm
Primary Device IDJ01854441
NIH Device Record Keyd6d38196-7959-4a15-941e-2f4e8fd95498
Commercial Distribution StatusIn Commercial Distribution
Brand NameTelescopes
Version Model Number5444.1
Company DUNS317683787
Company NameScheu-Dental GmbH
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCJ01854441 [Primary]

FDA Product Code

DYJRetainer, Screw Expansion, Orthodontic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-11-27
Device Publish Date2024-11-19

On-Brand Devices [Telescopes]

J01854541Telescopes HF 9, 1 pair
J01854491Telescopes HF 5, 1 pair
J01854441Telescopes HF 15, 1 pair

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