DEVICE: GEM MICROTRAY MAX (00844735005868)

Device Identifier (DI) Information

GEM MICROTRAY MAX
GEM2551-CS
In Commercial Distribution
519311006011
SYNOVIS MICRO COMPANIES ALLIANCE, INC
00844735005868
GS1

1
031284586 *Terms of Use
The GEM MicroTray MAX System consists of a reusable Anastomotic Instrument, two reusable COUPLER Forceps, a reusable Double-Ended Vessel Measuring Gauge, two MircoClip Appliers and a single tier MicroTray 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
HTD FORCEPS
GDO Applier, surgical, clip
MDM INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
KCT Sterilization wrap containers, trays, cassettes & other accessories
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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

[?]
Storage and Handling
Storage Environment Temperature: between 68 and 77 Degrees Fahrenheit
Storage Environment Temperature: between 20 and 25 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

2f830b73-869b-43fd-9fc6-10377e60cc8b
July 21, 2023
7
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

[?]
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
No
No
No CLOSE

Customer Contact

[?]
+1(800)933-0303
Medinfo_medproducts@baxter.com
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