DEVICE: NA (04055207050828)

Device Identifier (DI) Information

NA
4170801
In Commercial Distribution
4170.801
Richard Wolf GmbH
04055207050828
GS1

1
315304071 *Terms of Use
TEM TUBE SET insufflation tube, irrigation tube, suction tube, tube for pressure measurement, tube for roller pumps, connection tube for irrigation cannulas to roller pumps, PVC, for TEM pumps, sterile, for single use
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Device Characteristics

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

GMDN

[?]

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
HIF INSUFFLATOR, LAPAROSCOPIC
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No 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

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Size Type Text
No Device Sizes
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Device Record Status

1c32032b-ab25-4f67-ad31-8e6f8b13f1c5
February 07, 2019
6
June 28, 2017
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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
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
Yes
No
No CLOSE

Customer Contact

[?]
+497043350
info@richard-wolf.com
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