DEVICE: Telfa (20749915001699)

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Device Record History
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Device Identifier (DI) Information
Telfa
80-06
In Commercial Distribution

AMERICAN SURGICAL COMPANY, LLC
20749915001699
GS1

20
151054954 *Terms of Use
Telfa 1/2" x 1/2"
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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?
13702 Neurosurgical sponge
A sterile absorbent material intended to be used on the brain to remove blood and other fluids during an operation. This is a single-use device.
Active 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 [?]
K904514 000
No 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
01bf91a2-3699-4a89-a1cd-a3d89ef671c9
July 06, 2018
3
June 16, 2016
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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

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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: 10749915001692 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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