DEVICE: SURGICOUNT (57613327513139)

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Device Record History
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Device Identifier (DI) Information
SURGICOUNT
0623260050
In Commercial Distribution
0623-260-050
STRYKER CORPORATION
57613327513139
GS1

400
196548481 *Terms of Use
+ OR Towel, Green, RFID, X-Ray, 5/Pack
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Device Characteristics
MR Safe
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
38496 Radiopaque woven surgical sponge
A non-medicated device made from woven gauze (e.g., cotton, cellulose) primarily intended to be used inside the body, on a surgical incision or applied to internal organs or structures to control bleeding, absorb fluid, or protect organs or structures from abrasion, drying, or contamination during a procedure; also referred to as a laparotomy sponge, it may also be used for prepping the patient. It contains an x-ray detectable marker [e.g., a thread or strand(s)] to help detect gossypiboma (sponge left inside patient). This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
GDY GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization
No
Yes
Sterilization Method [?]
Ethylene Oxide
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Storage and Handling

[?]
Storage and Handling
Handling Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Handling Environment Temperature: between -20 and 50 Degrees Celsius
Storage Environment Temperature: between -20 and 50 Degrees Celsius
Handling Environment Atmospheric Pressure: between 50 and 106 KiloPascal
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
ee85c819-928d-4b5b-911a-99b8bc2f39bf
August 02, 2022
2
July 10, 2021
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: 07613327513134 CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
+0018002533210
Inst.Stryker.cs@Stryker.com
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