FDA.report

ExpandOR

Primary DI
00818089020372
Brand
ExpandOR
Company
NDS SURGICAL IMAGING, LLC
Model
90T0022
Device description
ExpandOR, DVI, Audio, ND-00B-R17/0
Published
2017-03-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
GCJLaparoscope, General & Plastic Surgery
LMDSystem, Digital Image Communications, Radiological

Product Code Classifications

CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2
LMDSystem, Digital Image Communications, RadiologicalRadiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00818089020372PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00818089020372008180890203728180890203720818089020372

GMDN Terms

TermDefinition
Image display monitor, colourA mains electricity (AC-powered) visual display unit (VDU), commonly known as a screen or a monitor, used for displaying graphical information under program control in colour, e.g., measured values or images from other devices. Colour is necessary when separating the information of multiple parameters making it easier for the user to read the values. A keyboard may be connected to the unit for interactive manipulation of the data by an operator. This GMDN code is the product identifier for the monitor only, which will not include the device(s) from which the data is generated and includes different screen technologies, e.g., cathode-ray tube (CRT) or liquid crystal display (LCD).

Sterilization Methods

Method

Contacts

PhoneEmail
1-408-776-0085info@ndssi.com

Regulatory Flags

DUNS number
959691940
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00818089022925EndoVue 90X07232022-02-04
00851455007812Radiance 90X06702022-02-04
00851455007836Radiance 90X06722022-02-04
00818089022642Radiance 90X07182021-12-15
00818089022673Radiance 90X07192021-12-15
00818089022772Radiance 90X07212021-12-15
00818089022789Radiance 90T21102021-10-13
00818089022796ZeroWire G2 90T21112021-10-13
00818089022833Radiance 90X07202021-10-13
00818089022710ZeroWire 90T21042021-09-27
00818089022727ZeroWire 90T21052021-09-27
00818089022734ZeroWire 90T21062021-09-27
00818089022741ZeroWire 90T21072021-09-27
00818089022758ZeroWire 90T21082021-09-27
00818089022765ZeroWire 90T21092021-09-27
00818089022611Radiance 90X07172021-06-08
00851455007003ZEROWIRE90T20062016-09-23
00851455007010ZEROWIRE90T20052016-09-23
00851455007027ZEROWIRE90T20042016-09-23
00851455007034ZEROWIRE90T20092016-09-20

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