FDA.reportPublic FDA data

ZeroWire

Primary DI
00818089022727
Brand
ZeroWire
Company
Nds Surgical Imaging LLC
Model
90T2105
Device description
MEDTRONIC ZEROWIRE G2 RECEIVER ONLY
Published
2021-09-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Product Codes#

Code, Name table
CodeName
GCJLaparoscope, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K151609000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151609000ZeroWire Duo Wireless HD Video Transfer System G2 or ZeroWire G2Nds Surgical Imaging, LLC2015-11-06GCJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00818089022727PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00818089022727008180890227278180890227270818089022727

GMDN Terms#

Term, Definition table
TermDefinition
Medical networking interface unitAn electronic unit or device assembly intended to be used to interface multiple noninvasive devices for digital communication of clinical data, typically from a patient data gathering point (e.g., patient monitor, in vitro diagnostic analyser) to a computer/network server; it is not intended to store data, display data/images, or control other devices. It may be a router, network switch, wireless transmitter and/or receiver, or cellular device intended for wired and/or wireless transmission of data. It is not ambulatory and not patient worn.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity0 Percent (%) Relative Humidity70 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
081712583
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00818089022437Radiance90R01302026-02-10
00818089023007Radiance 90Z03032022-10-15
00818089023014Radiance 90Z03042022-10-15
00818089022659ZeroWire G2 90Z1782022-08-11
00818089022697ZeroWire G2 90Z01632022-08-11
00818089022703ZeroWire G2 90Z01542022-08-11
00818089022840ZeroWire G2 90Z01802022-08-11
00818089022857ZeroWire G2 90Z01972022-08-11
00818089022864ZeroWire G2 90Z01992022-08-11
00818089020938Radiance 90X06022022-08-05
00818089020952Radiance 90X06062022-08-05
00818089020969Radiance 90X06122022-08-05
00818089021096Radiance 90X06562022-08-05
00818089021553Radiance 90X05992022-08-05
00818089021577Radiance 90X066592022-08-05
00818089022680ZeroWire G2 90X06122022-08-05
00818089022819ZeroWire G2 90T21132022-08-01
00818089022826ZeroWire G2 90T21142022-08-01
00818089022741ZeroWire 90T21072021-09-27
00818089022758ZeroWire 90T21082021-09-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506044366ELMEDELMED INCORPORATEDGCJ2026-06-09
00812231033906PixaSANTA BARBARA IMAGING SYSTEMS, INC.GCJ2026-06-08
00812231033913PixaSANTA BARBARA IMAGING SYSTEMS, INC.GCJ2026-06-08
00812231033920PixaSANTA BARBARA IMAGING SYSTEMS, INC.GCJ2026-06-08
00812231034095PixaSANTA BARBARA IMAGING SYSTEMS, INC.GCJ2026-06-08
00812231034101PixaSANTA BARBARA IMAGING SYSTEMS, INC.GCJ2026-06-08
04717480900336Inno-PortTAIWAN SURGICAL CORPORATIONGCJ2026-06-08
04717480900343Inno-PortTAIWAN SURGICAL CORPORATIONGCJ2026-06-08
04717480900350Inno-PortTAIWAN SURGICAL CORPORATIONGCJ2026-06-08
04717480900367Inno-PortTAIWAN SURGICAL CORPORATIONGCJ2026-06-08
04717480900398Inno-PortTAIWAN SURGICAL CORPORATIONGCJ2026-06-08
04717480900404Inno-PortTAIWAN SURGICAL CORPORATIONGCJ2026-06-08
04717480900763Inno-PortTAIWAN SURGICAL CORPORATIONGCJ2026-06-08
04717480900770Inno-PortTAIWAN SURGICAL CORPORATIONGCJ2026-06-08
04717480900787Inno-PortTAIWAN SURGICAL CORPORATIONGCJ2026-06-08
04717480900800Inno-PortTAIWAN SURGICAL CORPORATIONGCJ2026-06-08
E496C05HPDH0Handle for pneumodissection HookAB MEDICAGCJ2026-06-08
E496C05IDCH20ST1Hook insert and tube for pneumodissection D=5,0mm Lg=20cm, sterile single useAB MEDICAGCJ2026-06-08
E496C05IDCH33ST1Hook insert and tube for pneumodissection D=5,0mm Lg=33cm, sterile single useAB MEDICAGCJ2026-06-08
E496C35IDCH20ST1Hook insert and tube for pneumodissection D=3,5mm Lg=20cm, sterile single useAB MEDICAGCJ2026-06-08
E496C35IDCH33ST1Hook insert and tube for pneumodissection D=3,5mm Lg=33cm, sterile single useAB MEDICAGCJ2026-06-08
00198506091414ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-06-05
00198506091421ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-06-05
00198506091438ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-06-05
00198506091247ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-06-03
00198506091254ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-06-03
00192896123427TrocarSONTEC INSTRUMENTS, INC.GCJ2026-06-02
00192896123434Flexible Trocar SleeveSONTEC INSTRUMENTS, INC.GCJ2026-06-02
E496C35BTU200C35-Bipolar Tube L 20cm D 3,5mmAB MEDICAGCJ2026-05-28
E496C35IBDM200C35- Bipolar Maryland Insert L20cm D 3,5mmAB MEDICAGCJ2026-05-28