DEVICE: Dealmed (00859140003682)

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Device Record History
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Device Identifier (DI) Information
Dealmed
783014
In Commercial Distribution
783014
DEALMED MEDICAL SUPPLIES LLC
00859140003682
GS1

100
068586441 *Terms of Use
Gauze Pad Woven Sterile 4" x 4" 12-Ply 1's, 100/Bx
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Device Characteristics
Labeling does not contain MRI Safety Information
No
Yes
Yes
No
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?
58803 Radiopaque non-woven surgical sponge, non-sterile
A non-medicated non-sterile device made from a non-woven absorbent material (e.g., rayon/polyester) 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 is intended to produce less lint than woven gauze and 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 intended to be sterilized prior to use.
Obsolete false
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FDA Product Code

[?]
Product Code Product Code Name
NAB Gauze / sponge,nonresorbable for external use
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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
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: 4" x 4"
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Device Record Status
336832c4-b020-4a54-bb61-d8c9c37485b5
December 14, 2020
1
December 04, 2020
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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
10859140003689 12 00859140003682 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: 00859140003484 CLOSE

Direct Marking (DM)

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

[?]
Yes
No
No
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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