PillCam

Primary DI
07290101363200
Brand
PillCam
Company
Given Imaging, Inc.
Model
FGS-0155
Catalog number
FGS-0155
Device description
sensor array, DR2 3-lead
Published
2016-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NSISYSTEM, IMAGING, ESOPHAGEAL, WIRELESS, CAPSULE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NSISystem, Imaging, Esophageal, Wireless, CapsuleGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K071153000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K071153000GIVEN DIAGNOSTIC SYSTEM WITH PILLCAM ESO2 CAPSULEGiven Imaging , Ltd.2007-06-11NSI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290101363200PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290101363200072901013632007290101363200

GMDN Terms#

Term, Definition table
TermDefinition
Video capsule endoscopy systemAn 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep dry;Fragile;

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(508)261-8000covidien.udi@covidien.com

Regulatory Flags#

DUNS number
090073722
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290101365921ManoScanFGS-05712017-07-20
07290101369578ManoViewFGS-06282019-08-11
10884521855441ManoScanFGS-07152025-08-21
07290101364221PillCamRFB-03472017-02-02
04260167480954ManoScan38852016-09-24
04260167480961ManoScan38872016-09-24
04260167482446ManoScan38902016-09-24
04260167482460ManoScan21952016-09-24
04260167482477ManoScan21922016-09-24
04260167482484ManoScan12862016-09-24
07290101365686PillCamRFB-01542016-09-24
10884521853317ManoScanFGS-80382025-01-25
10884521846975PillCam GeniusFGS-08062024-11-29
10884521845848PillCam GeniusFGS-06892024-11-29
20884521845845PillCam GeniusFGS-06892024-11-29
10884521845831PillCam GeniusFGS-06882024-11-14
10884521845916PillCamFGS-08022024-11-14
10884521845923PillCamFGS-08032024-11-14
10884521836181PillCamFGS-07072023-10-05
07290101364474PillcamRFB-03552017-02-02