SURGICOUNT 0631-008-108

GUDID 57613327513207

+ SAFE-T-Lap Sponge, 8 inch x 108 inch, RFID, X-Ray

STRYKER CORPORATION

Radiopaque woven surgical sponge, non-sterile
Primary Device ID57613327513207
NIH Device Record Keycf2cf22c-b4a4-4205-874a-819900c46dd5
Commercial Distribution StatusIn Commercial Distribution
Brand NameSURGICOUNT
Version Model Number0631008108
Catalog Number0631-008-108
Company DUNS196548481
Company NameSTRYKER CORPORATION
Device Count1
DM Exemptfalse
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

Phone+0018002533210
EmailInst.Stryker.cs@Stryker.com
Phone+0018002533210
EmailInst.Stryker.cs@Stryker.com
Phone+0018002533210
EmailInst.Stryker.cs@Stryker.com
Phone+0018002533210
EmailInst.Stryker.cs@Stryker.com
Phone+0018002533210
EmailInst.Stryker.cs@Stryker.com
Phone+0018002533210
EmailInst.Stryker.cs@Stryker.com
Phone+0018002533210
EmailInst.Stryker.cs@Stryker.com
Phone+0018002533210
EmailInst.Stryker.cs@Stryker.com
Phone+0018002533210
EmailInst.Stryker.cs@Stryker.com
Phone+0018002533210
EmailInst.Stryker.cs@Stryker.com
Phone+0018002533210
EmailInst.Stryker.cs@Stryker.com
Phone+0018002533210
EmailInst.Stryker.cs@Stryker.com
Phone+0018002533210
EmailInst.Stryker.cs@Stryker.com
Phone+0018002533210
EmailInst.Stryker.cs@Stryker.com
Phone+0018002533210
EmailInst.Stryker.cs@Stryker.com
Phone+0018002533210
EmailInst.Stryker.cs@Stryker.com
Phone+0018002533210
EmailInst.Stryker.cs@Stryker.com
Phone+0018002533210
EmailInst.Stryker.cs@Stryker.com
Phone+0018002533210
EmailInst.Stryker.cs@Stryker.com
Phone+0018002533210
EmailInst.Stryker.cs@Stryker.com
Phone+0018002533210
EmailInst.Stryker.cs@Stryker.com
Phone+0018002533210
EmailInst.Stryker.cs@Stryker.com
Phone+0018002533210
EmailInst.Stryker.cs@Stryker.com
Phone+0018002533210
EmailInst.Stryker.cs@Stryker.com
Phone+0018002533210
EmailInst.Stryker.cs@Stryker.com
Phone+0018002533210
EmailInst.Stryker.cs@Stryker.com
Phone+0018002533210
EmailInst.Stryker.cs@Stryker.com

Operating and Storage Conditions

Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS107613327513202 [Primary]
GS137613327513203 [Package]
Contains: 07613327513202
Package: pack [1 Units]
In Commercial Distribution
GS157613327513207 [Package]
Contains: 37613327513203
Package: case [40 Units]
In Commercial Distribution

FDA Product Code

GDYGAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-07-05
Device Publish Date2021-06-25

On-Brand Devices [SURGICOUNT]

07613327298345SurgiCount? Tablet Pole Mount
07613327298338SurgiCount? Tablet Dock
07613327298321SurgiCount? Tablet Wall Mount
07613327298314SurgiCount? Power Supply
07613327298307SurgiCount? Tablet Battery
07613327298291SurgiCount? Dock Wall Mount
07613327298284SurgiCount? Tablet
07613327545364APPLICATION
07613327513301+ CRADLE POLE MOUNT
07613327513295+ CRADLE
57613327512682+ Gauze Sponge, 4 inch x 4 inch, 16 Ply, RFID, Double Wavy X-Ray
57613327513207+ SAFE-T-Lap Sponge, 8 inch x 108 inch, RFID, X-Ray
07613327513189+ SAFE-T-Lap Sponge, 8 inch x 36 inch, RFID, X-Ray
07613327513127+ OR Towel, Blue, RFID, X-Ray, 5/Pack
07613327513097+ OR Towel, Green, RFID, X-Ray, 2/Pack
07613327513073+ OR Towel, Blue, RFID, X-Ray, 2/Pack
07613327512762+ SAFE-T-Lap Sponge, 18 inch x 18 inch, RFID, X-Ray, No Loop
07613327512755+ SAFE-T-Lap Sponge, 18 inch x 36 inch, RFID, X-Ray
07613327512748+ SAFE-T-Lap Sponge, 18 inch x 18 inch, RFID, X-Ray, Plastic Ring
07613327512731+ SAFE-T-Lap Sponge, 12 inch x 12 inch, RFID, X-Ray
07613327512724+ SAFE-T-Lap Sponge, 8 inch x 36 inch, RFID, X-Ray, Plastic Ring
07613327512717+ SAFE-T-Lap Sponge, 18 inch x 18 inch, RFID, X-Ray
07613327512700+ SAFE-T-Lap Sponge, 4 inch x 18 inch, RFID, X-Ray
37613327512565+ Gauze Sponge, 8 inch x 4 inch, 24 Ply, RFID, Double X-Ray
07613327512557+ Gauze Sponge, 8 inch x 4 inch, 16 Ply, RFID, Double X-Ray
07613327512540+ Gauze Sponge, 4 inch x 4 inch, 32 Ply, RFID, Double X-Ray
07613327512533+ Gauze Sponge, 8 inch x 4 inch, 12 Ply, RFID, Double X-Ray
07613327512526+ Gauze Sponge, 4 inch x 4 inch, 16 Ply, RFID, Double X-Ray
57613327519506+ SPONGE COUNTING BAG
57613327517977+ READER COVER
57613327513177+ Gauze Sponge, 8 inch x 4 inch, 12 Ply, RFID, Double X-Ray
57613327512866+ OR Towel, Blue, RFID, X-Ray, 2/Pack
57613327512842+ SAFE-T-Lap Sponge, 18 inch x 36 inch, RFID, X-Ray
57613327512835+ SAFE-T-Lap Sponge, 18 inch x 18 inch, RFID, X-Ray, No Loop
57613327512828+ SAFE-T-Lap Sponge, 8 inch x 36 inch, RFID, X-Ray, Plastic Ring
57613327512811+ SAFE-T-Lap Sponge, 18 inch x 18 inch, RFID, X-Ray, Plastic Ring
57613327512804+ SAFE-T-Lap Sponge, 18 inch x 18 inch, RFID, X-Ray
57613327512798+ SAFE-T-Lap Sponge, 8 inch x 36 inch, RFID, X-Ray
57613327512781+ SAFE-T-Lap Sponge, 12 inch x 12 inch, RFID, X-Ray
57613327512774+ SAFE-T-Lap Sponge, 4 inch x 18 inch, RFID, X-Ray
57613327512699+ Gauze Sponge, 8 inch x 4 inch, 24 Ply, RFID, Double X-Ray
57613327512675+ Gauze Sponge, 8 inch x 4 inch, 16 Ply, RFID, Double X-Ray
57613327512668+ Gauze Sponge, 4 inch x 4 inch, 32 Ply, RFID, Double X-Ray
57613327512644+ Gauze Sponge, 4 inch x 4 inch, 16 Ply, RFID, Double X-Ray
07613327543094+ APPLICATION
07613327519525+ STAND
07613327519518+ CRADLE WALL MOUNT
07613327515855+ READER
07613327513141+ OR Towel, White, RFID, X-Ray, 5/Pack
07613327513134+ OR Towel, Green, RFID, X-Ray, 5/Pack

Trademark Results [SURGICOUNT]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SURGICOUNT
SURGICOUNT
78871542 3703648 Live/Registered
STRYKER CORPORATION
2006-04-27

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