DEVICE: Hemostat Gauze Dressing (00616784368719)

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Device Record History
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Device Identifier (DI) Information
Hemostat Gauze Dressing
3687
In Commercial Distribution

Dynarex Corporation
00616784368719
GS1

1
008124539 *Terms of Use
Hemostat Gauze Dressing, 4"x4"
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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?
64869 Plant polysaccharide/inorganic composite haemostatic agent
A bioabsorbable device consisting of a combination of both: 1) plant polysaccharide-based; and 2) inorganic (i.e., not derived from living matter) synthetic polymer-based [e.g., polyethylene glycol (PEG)] haemostatic agents, intended to be used to achieve haemostasis during an open and/or endoscopic surgical procedure. It is available in various forms (e.g., powder, gel, impregnated gauze); it does not contain an antimicrobial agent. Disposable devices to assist application may also be included. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
FRO Dressing, Wound, Drug
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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
b094628f-8f05-40a9-a1e1-db01cc17e909
October 09, 2024
2
June 21, 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
00616784368726 20 00616784368719 In Commercial Distribution Box
00616784368733 10 00616784368726 In Commercial Distribution Case
00616784368740 8 00616784368733 In Commercial Distribution Shipper
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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

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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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