OSE

GUDID 00810042120013

Palatal Swivel Key

ORTHODONTIC SUPPLY & EQUIPMENT COMPANY INC

Orthodontic palate expander key Orthodontic palate expander key Orthodontic palate expander key Orthodontic palate expander key
Primary Device ID00810042120013
NIH Device Record Keyd2867c9a-b532-4573-aff5-4fb4e5f7488d
Commercial Distribution StatusIn Commercial Distribution
Brand NameOSE
Version Model Number0195-KEY
Company DUNS077801124
Company NameORTHODONTIC SUPPLY & EQUIPMENT COMPANY INC
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100810042120013 [Primary]
GS100810042120013 [Primary]
GS100810042120013 [Primary]
GS100810042120013 [Primary]

FDA Product Code

DYJRetainer, Screw Expansion, Orthodontic
DYJRetainer, Screw Expansion, Orthodontic
DYJRetainer, Screw Expansion, Orthodontic
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 Date2020-05-21
Device Publish Date2020-05-13

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00869843000260Zinc Phosphate Cement Powder
00869843000253Zinc Phosphate Cement Kit
00869843000246Glass Ionomer Cement
00810042122482Super Elastic Nickel Titanium Archwires Natural Form .017 x .025 Upper
00810042122475Super Elastic Nickel Titanium Archwires Natural Form .016 x .022 Upper
00810042122468Super Elastic Nickel Titanium Archwires Natural Form .016 x .016 Upper
00810042123946ULTIMATE Ball Clasps .028
00810042121157Bonding Pads - Central Narrow
00810042121140Bonding Pads - Lower Anterior
00810042121133Bonding Pads - Cuspid Wide
00810042121126Bonding Pads - Central Wide
00810042120068Bonding Pads - Lateral
00810042120051Bonding Pads - Bicuspid Narrow
00810042121379Strengtheners - Stainless Steel, Bag of 50
00810042121164Labial Archwires - Maxillary 1-3\4"
00810042121119100 Split Stops and Spacers - .021 x .025
008100421211026" X 6" Stainless Steel Wire Mesh - Coarse
008100421210966" X 6" Stainless Steel Wire Mesh - Fine
00810042121089Lingual Bars - Extra Large
00810042121072Lingual Bars - Large
00810042121065Lingual Bars - Medium
00810042121058Lingual Bars - Small
00810042121041Arrowhead Clasps - .032
00810042121034Arrowhead Clasps - .028
00810042121027Round Buccal Tubing - .051
00810042121010Round Buccal Tubing - .045
00810042121003Round Buccal Tubing - .040
00810042122116Stainless Steel Closed Coil Spring - 3 x 12" - .010 x .030
00810042124455COPPER - 27°C Super Elastic Nickel Titanium Archwires Natural Form .017 x .025 Upper
00810042124448COPPER - 27°C Super Elastic Nickel Titanium Archwires Natural Form .016 x .022 Upper
00810042124431COPPER - 27°C Super Elastic Nickel Titanium Archwires Natural Form .016 x .016 Upper
00810042124424COPPER - 27°C Super Elastic Nickel Titanium Archwires Natural Form .018 Lower
00810042124417COPPER - 27°C Super Elastic Nickel Titanium Archwires Natural Form .016 Lower
00810042124400COPPER - 27°C Super Elastic Nickel Titanium Archwires Natural Form .014 Lower
00810042124394COPPER - 27°C Super Elastic Nickel Titanium Archwires Natural Form .013 Lower
00810042124387COPPER - 27°C Super Elastic Nickel Titanium Archwires Natural Form .018 Upper
00810042124370COPPER - 27°C Super Elastic Nickel Titanium Archwires Natural Form .016 Upper
00810042124363COPPER - 27°C Super Elastic Nickel Titanium Archwires Natural Form .014 Upper
00810042124356COPPER - 27°C Super Elastic Nickel Titanium Archwires Natural Form .013 Upper
00810042124226Nickel Titanium Open Coil Spring .014 x .036 - 15"
00810042124219Nickel Titanium Open Coil Spring .014 x .036 - 21"
00810042124202Nickel Titanium Open Coil Spring .012 x .036 - 15"
00810042124196Nickel Titanium Open Coil Spring .012 x .030 - 15"
00810042124189Nickel Titanium Open Coil Spring .012 x .030 - 21"
00810042124172Nickel Titanium Open Coil Spring .012 x .045 - 15"
00810042124165Nickel Titanium Open Coil Spring .010 x .030 - 15"
00810042124158Nickel Titanium Open Coil Spring .010 x .030 - 21"
00810042124141Nickel Titanium Open Coil Spring .010 x .036 - 15"

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