Safety Release Modules

GUDID 00190730002884

Safety Module Plastic Med 10pk 600gm

ORTHO TECHNOLOGY, INC.

Orthodontic extraoral headgear
Primary Device ID00190730002884
NIH Device Record Keya7f15001-a3c1-4280-a489-0f63eb95525c
Commercial Distribution StatusIn Commercial Distribution
Brand NameSafety Release Modules
Version Model Number550-100
Company DUNS781772017
Company NameORTHO TECHNOLOGY, INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
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
GS100190730002884 [Primary]

FDA Product Code

DZBHeadgear, extraoral, orthodontic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-24

On-Brand Devices [Safety Release Modules]

00190730007377Safety Module Steel Hvy 10/pk 750gm
00190730007360Safety Module Steel Med 10/pk 600gm
00190730002891Safety Module Plastic Hvy 10pk 750gm
00190730002884Safety Module Plastic Med 10pk 600gm

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