DEVICE: GI Trolly Gold (08717775955795)

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Device Record History
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Device Identifier (DI) Information
GI Trolly Gold
GI Trolly Gold
In Commercial Distribution

Medical Measurement Systems B.V.
08717775955795
GS1

1
416277333 *Terms of Use
No description.
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Device Characteristics
Labeling does not contain MRI Safety Information
No
Yes
No
No
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?
15036 Gastroduodenal motility analysis system
An assembly of devices designed to evaluate peristaltic motility in the stomach and/or small intestines (usually the duodenum) by measuring pressure on an intragastric catheter/probe at several points. It typically includes a monitor display, computer, software, pressure catheter/probe, and a pH electrode to measure the acidity of the stomach contents. The system is intended to evaluate several diseases of the stomach and small intestines including the prediction of gastric and/or duodenal ulcers.
Obsolete false
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FDA Product Code

[?]
Product Code Product Code Name
FFX SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL)
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization
No
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
588a7bb9-7f26-44b9-a78e-73571f65aee7
March 29, 2018
2
September 23, 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
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

[?]
No
Yes
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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