DEVICE: Y-switch with irrigation tube for motor 2, elco MED SA 200 / SA 200C (04251783104133)

Device Identifier (DI) Information

Y-switch with irrigation tube for motor 2, elco MED SA 200 / SA 200C
04366300
In Commercial Distribution

Assamed GmbH - Medizinbedarf
04251783104133
GS1

1
319354346 *Terms of Use
Y-switch with irrigation tube for motor 2, elco MED SA 200 / SA 200C
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
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?
46102 Surgical irrigation tubing set, single-use
A collection of flexible, noninvasive, single-lumen tubing and associated items intended to provide a conduit to deliver a sterile irrigation solution (e.g., saline) from its source (e.g., gravity feed bag, feed pump) to a surgical cannula (not included) during a surgical procedure (endoscopy, laparoscopy); it is not intended to navigate through an anatomical lumen. The tubing set includes devices such as clamps, filters, spikes, and Y-piece connectors, and may in addition include an integrated manual pump (e.g., a squeeze bulb) or handpiece. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
GBX Catheter, Irrigation
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes 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

58da3bf6-59d5-44c5-8937-d5b423dbe254
April 07, 2023
1
March 30, 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
14251783104130 4 04251783104133 In Commercial Distribution
24251783104137 104 04251783104133 In Commercial Distribution
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Secondary DI

[?]
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

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
+49(0)682681155
thomas.flamm@assamed.de
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