DEVICE: TwoVu (00866497000356)

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Device Record History
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Device Identifier (DI) Information
TwoVu
ST-6
In Commercial Distribution
TVST-6
Cannuflow, Inc.
00866497000356
GS1

1
138461384 *Terms of Use
Outflow Sheath
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Device Characteristics
Labeling does not contain MRI Safety Information
No
Yes
Yes
Yes
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?
64120 Surgical irrigation/aspiration cannula, non-illuminating, single-use
An atraumatic, invasive, hand-operated tube designed as a conduit for irrigation and aspiration (i.e., capable of both functions) of body cavities/wounds during a surgical procedure (typically laparoscopy), usually to facilitate observation. It is not dedicated to dental or intrauterine procedures, not an ophthalmic device, and is not designed to administer parenteral fluids or drugs. It might incorporate a handle with a valve(s) and hole(s) on its side for the control of irrigation/aspiration, and may be provided with a stylet, a sheath, and/or connection tubing; it is typically made of metal. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
FGY Cannula, Injection
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization
Yes
Yes
Sterilization Method [?]
Radiation Sterilization
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
Length: 113 Millimeter
Outer Diameter: 5.8 Millimeter
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Device Record Status
0b8258bc-48d7-4406-abe7-5d01034458de
January 24, 2024
1
January 16, 2024
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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
20866497000350 5 00866497000356 In Commercial Distribution Shelf Box
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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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