DEVICE: Americot (00749915002647)

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Device Record History
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Device Identifier (DI) Information
Americot
20-04SNS
In Commercial Distribution

AMERICAN SURGICAL COMPANY, LLC
00749915002647
GS1

1
151054954 *Terms of Use
Americot Blue 1/2" x 1/2" Non Sterile
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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?
32572 Cottonoid pad
A cushion-like mass made of cotton or man-made fibres used during surgery (e.g., neurosurgery) to protect tissue, absorb fluids, and/or stop bleeding. This is a single-use device.
Obsolete false
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FDA Product Code

[?]
Product Code Product Code Name
HBA Neurosurgical Paddie
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K854713 000
No CLOSE

Sterilization
No
Yes
Sterilization Method [?]
Ethylene Oxide
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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
33ca3b00-0941-40a1-88b7-31771137482b
December 24, 2019
1
December 16, 2019
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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
No Package DIs found
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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)

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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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