DEVICE: Vistec (10884521083929)

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Device Record History
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Device Identifier (DI) Information
Vistec
28750
In Commercial Distribution
28750
Cardinal Health, Inc.
10884521083929
GS1

5
080935429 *Terms of Use
X-Ray Detectable Sponges,12 Ply
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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
Width: 4 Inch
Length: 8 Inch
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Device Record Status
eefe96e1-0b98-4750-a582-2d87fe0a93e0
August 24, 2021
3
June 23, 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
20884521083926 1200 10884521083929 In Commercial Distribution CASE
30884521083923 150 10884521083929 In Commercial Distribution PACK_OR_INNER_PACK
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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: 40884521083920 CLOSE

Direct Marking (DM)

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

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
+1(508)261-8000
covidien.udi@covidien.com
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