DEVICE: Curity (10884527006519)

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Device Record History
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Device Identifier (DI) Information
Curity
6034
Not in Commercial Distribution
6034
Cardinal Health, Inc.
10884527006519
GS1
December 31, 2023
5
080935429 *Terms of Use
X-Ray Detectable Laparotomy Sponges,Tray Pack
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
Yes
No
Yes
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
Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: This side up;
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Clinically Relevant Size

[?]
Size Type Text
Length: 12 Inch
Width: 12 Inch
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Device Record Status
a2f8c9a5-4786-423b-af36-9450c9a95a36
January 01, 2024
5
June 30, 2018
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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
20884527006516 100 10884527006519 2023-12-31 Not in Commercial Distribution CASE
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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: 30884527006513 CLOSE

Direct Marking (DM)

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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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