DEVICE: Irrigation/Aspiration probe 16 holes, 5mmx45cm (00370512901471)

Device Identifier (DI) Information

Irrigation/Aspiration probe 16 holes, 5mmx45cm
RF16H545
In Commercial Distribution
RF16H545
Promepla
00370512901471
GS1

1
401020409 *Terms of Use
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
Yes
No
No
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Surgical irrigation/aspiration tubing set A collection of sterile, flexible, noninvasive, double-lumen tubing intended to provide twin conduits in a surgical irrigation/aspiration system, to deliver irrigation solution (e.g., saline) from its source (e.g., gravity feed bag) to a surgical field through one lumen, and provide aspiration (suction) through the other lumen (i.e., capable of both functions), during a surgical procedure (e.g., dental, laparoscopy). It may include associated items (e.g., clamps, valves, filters, spikes and connectors), and a manual pump for channelling between the irrigation source and the point of application. Some types may have additional tubing to assist gastric lavage. This is a single-use device.
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FDA Product Code

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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

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

404b2725-e1c5-49a8-8ec0-d53165f0edf1
February 07, 2019
3
September 15, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
03700512921479 60 03700512911470 In Commercial Distribution Box 2
03700512911470 10 00370512901471 In Commercial Distribution Box 1
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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
Yes
No
No CLOSE

Customer Contact

[?]
+37797984232
customer@rocamed.eu
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