DEVICE: Bioseal Inc. (00630094022857)

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Device Record History
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Device Identifier (DI) Information
Bioseal Inc.
2205F/25
In Commercial Distribution

BIOSEAL
00630094022857
GS1

1
186968939 *Terms of Use
Gauze Packing X-Ray Detectable
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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?
15047 Gauze packer
A hand-held, surgical instrument used for introducing and packing gauze or dressings into body cavities. This is a reusable 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
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
1dd2a1c9-6caa-4b20-b7f6-b51e6ae9b6d7
December 29, 2023
1
December 21, 2023
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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
10630094022854 25 00630094022857 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: No Unit of Use DI Numbers Found 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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