DEVICE: GEM Microvascular Anastomotic COUPLER System (00844735005226)

Device Identifier (DI) Information

GEM Microvascular Anastomotic COUPLER System
GEM 2741CC
In Commercial Distribution
519301006010
SYNOVIS MICRO COMPANIES ALLIANCE, INC
00844735005226
GS1

1
031284586 *Terms of Use
The GEM Microvascular Anastomotic COUPLER System consists of a reusable Anastomotic Instrument, two reusable COUPLER Forceps, a reusable Double-Ended Vessel Measuring Gauge, and reusable Microvascular Anastomotic COUPLER Sterilization Tray.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
Yes
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?
61239 Vascular anastomosis coupling kit, reusable
A collection of devices intended to be used to implant a vascular anastomosis coupler [not included] to join vascular (including microvascular) structures by the coupling of two ring-shaped components. It consists of two or more items typically amongst: a coupling approximator for holding the rings of the coupler during approximation, a dedicated forceps/everter for placing the ends of the blood vessel over the pins of the coupler, a vessel diameter guide (sizer), and a sterilization tray. This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
KCT Sterilization wrap containers, trays, cassettes & other accessories
MDM INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
HTD FORCEPS
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K071783 000
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Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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Storage and Handling

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Storage and Handling
Storage Environment Temperature: between 20 and 25 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

62e5fae7-e47d-4004-8735-1686ac4e165c
July 27, 2023
8
September 24, 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

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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

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Yes
No
No
Yes
No CLOSE

Customer Contact

[?]
+1(800)510-3318
smca_information@baxter.com
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