Custom Tray Resin FLCTBL01

GUDID 10860002099320

FORMLABS OHIO INC.

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Primary Device ID10860002099320
NIH Device Record Key2fdd3518-a945-4f87-bbfc-5c95c37e5679
Commercial Distribution StatusIn Commercial Distribution
Brand NameCustom Tray Resin
Version Model NumberFLCTBL01
Catalog NumberFLCTBL01
Company DUNS106744280
Company NameFORMLABS OHIO 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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Operating and Storage Conditions

Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of light
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of light
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of light
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of light
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of light
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of light
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of light
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of light
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of light
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of light
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of light
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of light
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of light
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of light
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of light
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of light
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of light

Device Identifiers

Device Issuing AgencyDevice ID
GS100860002099323 [Primary]
GS110860002099320 [Package]
Contains: 00860002099323
Package: Case [8 Units]
In Commercial Distribution

FDA Product Code

EBHMaterial, Impression Tray, Resin

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-15
Device Publish Date2020-07-07

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10860002099320 - Custom Tray Resin2020-07-15

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