Prime TC 1460-000-000

GUDID 07613327282665

STRYKER CORPORATION

Transport wheelchair, non-collapsible Transport wheelchair, non-collapsible Transport wheelchair, non-collapsible Transport wheelchair, non-collapsible Transport wheelchair, non-collapsible Transport wheelchair, non-collapsible Transport wheelchair, non-collapsible Transport wheelchair, non-collapsible Transport wheelchair, non-collapsible Transport wheelchair, non-collapsible Transport wheelchair, non-collapsible Transport wheelchair, non-collapsible Transport wheelchair, non-collapsible Attendant-only-propelled wheelchair, non-bariatric Attendant-only-propelled wheelchair, non-bariatric Attendant-only-propelled wheelchair, non-bariatric Attendant-only-propelled wheelchair, non-bariatric Attendant-only-propelled wheelchair, non-bariatric Attendant-only-propelled wheelchair, non-bariatric Attendant-only-propelled wheelchair, non-bariatric Attendant-only-propelled wheelchair, non-bariatric Attendant-only-propelled wheelchair, non-bariatric Attendant-only-propelled wheelchair, non-bariatric Attendant-only-propelled wheelchair, non-bariatric Attendant-only-propelled wheelchair, non-bariatric Attendant-only-propelled wheelchair, non-bariatric Attendant-only-propelled wheelchair, non-bariatric Attendant-only-propelled wheelchair, non-bariatric Attendant-only-propelled wheelchair, non-bariatric Attendant-only-propelled wheelchair, non-bariatric Attendant-only-propelled wheelchair, non-bariatric Attendant-only-propelled wheelchair, non-bariatric Attendant-only-propelled wheelchair, non-bariatric Attendant-only-propelled wheelchair, non-bariatric Attendant-only-propelled wheelchair, non-bariatric Attendant-only-propelled wheelchair, non-bariatric Attendant-only-propelled wheelchair, non-bariatric Attendant-only-propelled wheelchair, non-bariatric Attendant-only-propelled wheelchair, non-bariatric Attendant-only-propelled wheelchair, non-bariatric Attendant-only-propelled wheelchair, non-bariatric Attendant-only-propelled wheelchair, non-bariatric Attendant-only-propelled wheelchair, non-bariatric Attendant-only-propelled wheelchair, non-bariatric Attendant-only-propelled wheelchair, non-bariatric Attendant-only-propelled wheelchair, non-bariatric
Primary Device ID07613327282665
NIH Device Record Key4dfe925a-589e-438b-a16d-077c841ea356
Commercial Distribution StatusIn Commercial Distribution
Brand NamePrime TC
Version Model Number1460-000-000
Catalog Number1460-000-000
Company DUNS078470558
Company NameSTRYKER CORPORATION
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 Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing AgencyDevice ID
GS107613327282665 [Primary]

FDA Product Code

INNCHAIR, ADJUSTABLE, MECHANICAL

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-09-09
Device Publish Date2020-09-01

Devices Manufactured by STRYKER CORPORATION

07613327627664 - KNOTILUS+2024-03-15 2.9X12.5MM KNOTILUS+ HIP ANCHOR - PEEK
07613327627701 - KNOTILUS+2024-03-15 2.4X8.9MM KNOTILUS+ HIP ANCHOR - PEEK
07613327623796 - KNOTILUS+2024-03-13 2.4X8.9MM DRILL, HIP
07613327623833 - KNOTILUS+2024-03-13 2.4X8.9MM DRILL, HARD BONE, HIP
07613327634686 - Iconix2024-03-12 Iconix DC Guide for 1.4mm anchor
07613327634693 - Iconix2024-03-12
07613327616675 - SPY2024-03-06
07613327616682 - SPY2024-03-06

Trademark Results [Prime TC]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PRIME TC
PRIME TC
85861813 4544598 Live/Registered
Stryker Corporation
2013-02-27

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