DEVICE: SURGYCO (10850044799807)

Device Identifier (DI) Information

SURGYCO
PS011510
In Commercial Distribution

Surgyco LLC
10850044799807
GS1

50
118768538 *Terms of Use
Surgyco Disposable Medical Face Mask, ASTM Level 3, Earloop, 3 ply, Blue color
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Device Characteristics

Labeling does not contain MRI Safety Information
Yes
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?
47017 General-purpose syringe, single-use
A sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used for injection/withdrawal of fluids/gas (e.g., medication) to/from a medical device or the body (i.e., capable of both); a needle is not included. It is intended for various medical applications and is not dedicated to medication administration. At the distal end of the barrel is a male connector (typically Luer-lock/slip type) for the attachment to a hypodermic needle or an administration set. It is typically made of plastic and silicone materials and may have anti-stick plunger allowing smooth plunger movement, either manually or by a syringe pump. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
FXX Mask, Surgical
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K210433 000
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Sterilization

No
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

8288a8a4-3c6f-4c29-b164-a7f38a6a212e
February 24, 2023
1
February 16, 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
20850044799804 2000 10850044799807 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: 00850044799800 CLOSE

Direct Marking (DM)

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

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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