DEVICE: Pillcam (07290101366119)
Device Identifier (DI) Information
Pillcam
FGS-0581
In Commercial Distribution
FGS-0581
Covidien LP
FGS-0581
In Commercial Distribution
FGS-0581
Covidien LP
Velcro sleeve, downlink antenna
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
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 |
---|---|
Video capsule endoscopy system | An assembly of electronic devices designed for the internal visualization and examination of sections of the gastrointestinal (GI) tract using a non-digestible video capsule after it has been swallowed by a patient. The system typically consists of an operator workstation, various types of video capsules, an external sensor device that receives the wireless signals from the capsule, and a data recorder. As the capsule passes through the GI tract, video images of it sections (e.g., oesophagus, small bowel and colon) are relayed to the operator for examination and data recording; the capsule is egested from the gut. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
NEZ | SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K123864 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: ; |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
15e02f0f-76fc-4e55-b14b-0a763992e002
July 06, 2018
3
February 01, 2017
July 06, 2018
3
February 01, 2017
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 |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(508)261-8000
covidien.udi@covidien.com
covidien.udi@covidien.com