FDA.reportPublic FDA data

ZeroWire G2

Primary DI
00818089022659
Brand
ZeroWire G2
Company
Nds Surgical Imaging LLC
Model
90Z178
Device description
"ZeroWire G2 Duo Accessory Kit, Radiance Ultra 32"" / EndoVue 32"""
Published
2022-08-11
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
GCJLaparoscope, General & Plastic Surgery

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00818089022659PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00818089022659008180890226598180890226590818089022659

GMDN Terms#

Term, Definition table
TermDefinition
Medical networking interface unitAn electronic unit or device assembly intended to be used to interface one or more noninvasive devices for digital communication of clinical data, typically from a patient data gathering point (e.g., patient monitor/monitoring system) to a computer/network server; it is not intended to store data, display data/images, or control other devices. It may be an ethernet 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.

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
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
00818089022765ZeroWire 90T21092021-09-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506092183ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-07-29
00198506092640ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-07-29
00198506093562ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-07-29
00198506093838ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-07-29
B354OSRP80Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-07-29
00198506092435ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-07-28
00198506092855ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-07-28
00198506093289ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-07-28
00198506093388ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-07-28
00842102116452Deluxe Laparoscopic InstrumentsFLEXBAR MACHINE CORPORATIONGCJ2026-07-28
14026704645340WECKTELEFLEX INCORPORATEDGCJ2026-07-28
B382SD901365500Surgical DirectSurgical Direct, Inc.GCJ2026-07-28
00190776422110MillenniumAvalign Technologies, Inc.GCJ2026-07-24
00198506091957ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-07-22
00198506092848ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-07-22
00198506092862ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-07-22
14026704645333WECKTELEFLEX INCORPORATEDGCJ2026-07-21
00198506092176ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-07-17
00888867561793Arthrex®ARTHREX, INC.GCJ2026-07-17
B382SD90781001000Surgical DirectSurgical Direct, Inc.GCJ2026-07-17
B382SD9918100Surgical DirectSurgical Direct, Inc.GCJ2026-07-17
B382SD1184590Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD12711090Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD1271390Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD1271590Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD13018770Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD13168350Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD23373490Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD770561050Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD775011530Surgical DirectSurgical Direct, Inc.GCJ2026-07-14