Staclot® LA

GUDID 03607450006001

DIAGNOSTICA STAGO

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Primary Device ID03607450006001
NIH Device Record Key749d93d2-e16b-436a-9fae-20ee1c3b7574
Commercial Distribution StatusIn Commercial Distribution
Brand NameStaclot® LA
Version Model Number00600
Company DUNS262277122
Company NameDIAGNOSTICA STAGO
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS103607450006001 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GFOACTIVATED PARTIAL THROMBOPLASTIN

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2021-05-03
Device Publish Date2016-09-15

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03607450589894 - STA Compact Max® (with cap piercing option)2022-09-16
03607450589900 - STA Compact Max®2022-09-16
03607450590104 - STA R Max® (with cap piercing option)2022-09-16
03607450590135 - STA R Max®2022-09-16
03607450590265 - STA R Max®2022-09-16

Trademark Results [Staclot]

Mark Image

Registration | Serial
Company
Trademark
Application Date
STACLOT
STACLOT
78327230 3000846 Live/Registered
Diagnostica Stago
2003-11-13
STACLOT
STACLOT
73819346 1621815 Dead/Cancelled
DIAGNOSTICA STAGO
1989-08-15

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