Philips

GUDID 00884838120242

Biopsy Grid, Sterilized

Philips Medical Systems Nederland B.V.

Needle guide, single-use
Primary Device ID00884838120242
NIH Device Record Keyacdd8362-3bfa-42df-9c17-b1f48f6c8439
Commercial Distribution StatusIn Commercial Distribution
Brand NamePhilips
Version Model Number989603214204
Company DUNS413819707
Company NamePhilips Medical Systems Nederland B.V.
Device Count10
DM Exempttrue
Pre-market Exempttrue
MRI Safety StatusMR Safe
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 Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-722-9377
Emailxx@xx.xx
Phone1-800-722-9377
Emailxx@xx.xx
Phone1-800-722-9377
Emailxx@xx.xx
Phone1-800-722-9377
Emailxx@xx.xx
Phone1-800-722-9377
Emailxx@xx.xx
Phone1-800-722-9377
Emailxx@xx.xx
Phone1-800-722-9377
Emailxx@xx.xx
Phone1-800-722-9377
Emailxx@xx.xx
Phone1-800-722-9377
Emailxx@xx.xx
Phone1-800-722-9377
Emailxx@xx.xx
Phone1-800-722-9377
Emailxx@xx.xx
Phone1-800-722-9377
Emailxx@xx.xx
Phone1-800-722-9377
Emailxx@xx.xx
Phone1-800-722-9377
Emailxx@xx.xx
Phone1-800-722-9377
Emailxx@xx.xx
Phone1-800-722-9377
Emailxx@xx.xx
Phone1-800-722-9377
Emailxx@xx.xx

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 24 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 24 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 24 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 24 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 24 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 24 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 24 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 24 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 24 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 24 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 24 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 24 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 24 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 24 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 24 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 24 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 24 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100884838120242 [Primary]
GS100884838120259 [Unit of Use]

FDA Product Code

GDFGuide, Needle, Surgical

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-07-26
Device Publish Date2024-07-18

On-Brand Devices [Philips]

00884838118270dS Breast Coil 7ch 1.5T
00884838120242Biopsy Grid, Sterilized
00884838120211Breast Grid (User-Sterilized)
00884838118782BREAST 7 BIOPSY PACK, 1.5T contains - 3 Grid Immobilization Plate LBS M-L; 3 Pillar Immobilizati
00884838118775Kit, Enhanced Access, Bilateral Upgrade consists of Fiducial Marker Grid Block Assembly; 3 Grid
00884838118768dS Breast 16 Biopsy Pack, 1.5T contains - 4 Lateral Grid, Upper dS Breast 16Ch I/T; 4 Medial Gri
00884838118751Lateral Grid, Lower dS Breast 16CH I/T
00884838118744Lateral Grid, Upper dS Breast 16CH I/T
00884838118737Medial Grid dS Breast 16CH I/T
00884838118720Lateral Grid dS Breast 16CH I/T
00884838118713Grid Plate, Enhanced Access Medial
00884838118706Grid Plate Enhanced Access, Lateral
00884838118683Pillar Immobilization Plate
00884838118676Pillar Immobilization Plate LBS M-L
00884838118669Grid Immobilization Plate LBS M-L
00884838118652Pillar Immobilization Plate LBS C-C
00884838118645Grid Immobilization Plate LBS
00884838118621OBC Grid Immobilization Plate
00884838118614Mammotome Immobilization Plate
00884838118607Pillar Immobilization Plate
00884838118591Grid Immobilization Plate
00884838118584Needle Hub Assembly
00884838118577Fiducial Holder
00884838118560Needle Block Holder
00884838118553MRI Needle Sleeve18G
00884838118546MRI Sleeve Block 16G
00884838118539MRI Needle Sleeve 14G
00884838118522MRI Needle Sleeve 12G
00884838118515MRI Needle Block 18G
00884838118508MRI Needle Block 16G
00884838118492MRI Needle Block 14G
00884838118485MRI Needle Block 12G
00884838118478FIDUCIAL MARKER GRID BLOCK ASSEMBLY
00884838118461Fiducial Marker Sleeve Assembly
00884838118454MRI Needle Block 8G

Trademark Results [Philips]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PHILIPS
PHILIPS
97612977 not registered Live/Pending
KONINKLIJKE PHILIPS N.V.
2022-09-29
PHILIPS
PHILIPS
97612788 not registered Live/Pending
KONINKLIJKE PHILIPS N.V.
2022-09-29
PHILIPS
PHILIPS
90375000 not registered Live/Pending
KONINKLIJKE PHILIPS N.V.
2020-12-11
PHILIPS
PHILIPS
86895722 not registered Live/Pending
KONINKLIJKE PHILIPS N.V.
2016-02-03
PHILIPS
PHILIPS
86895717 not registered Live/Pending
KONINKLIJKE PHILIPS N.V.
2016-02-03
PHILIPS
PHILIPS
79399343 not registered Live/Pending
Koninklijke Philips N.V.
2024-04-25
PHILIPS
PHILIPS
79399341 not registered Live/Pending
Koninklijke Philips N.V.
2024-04-25
PHILIPS
PHILIPS
79162290 5038342 Live/Registered
Koninklijke Philips N.V.
2014-05-12
PHILIPS
PHILIPS
79064585 3864315 Live/Registered
Koninklijke Philips N.V.
2008-06-13
PHILIPS
PHILIPS
79064220 not registered Dead/Abandoned
Koninklijke Philips Electronics N.V.
2007-12-03
PHILIPS
PHILIPS
77935049 not registered Live/Pending
Louis Co
2010-02-12
PHILIPS
PHILIPS
75636845 not registered Dead/Abandoned
KONINKLIJKE PHILIPS ELECTRONICS N.V.
1999-02-09

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.