DEVICE: Post-Op Sponges (00616784334905)

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Device Record History
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Device Identifier (DI) Information
Post-Op Sponges
3349
In Commercial Distribution

Dynarex Corporation
00616784334905
GS1

1
008124539 *Terms of Use
Post-Op Sponges, Non-Woven, Sterile, 4" x 4", 4-Ply (10.2cm x 10.2cm)
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
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?
44971 General-purpose surgical sponge
A non-medicated cushion-like mass made of absorbent materials (e.g., woven gauze, 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 or cottonoid pad/pattie, it may also be used for prepping the patient. It does not contain special features to help detect gossypiboma (sponge left inside patient) [i.e., it is not radiopaque]. This is a single-use device.
Active 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
No Device Sizes
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Device Record Status
d7c5d494-5ef7-4a3a-943e-cc00e859de86
October 09, 2024
2
April 28, 2022
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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
00616784334912 2 00616784334905 In Commercial Distribution Pouch
00616784334929 25 00616784334912 In Commercial Distribution Box
00616784334936 24 00616784334929 In Commercial Distribution Case
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Secondary DI

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

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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

[?]
No
No
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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