FDA.reportPublic FDA data

Probe

Primary DI
00877972002772
Brand
Probe
Company
GENICON, INC.
Model
707-010-033
Published
2017-05-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K041967000
K190168000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K041967000GENICON SUCTION IRRIGATION SYSTEMGenicon2004-11-12GCJ
K190168000Aquas ProbesGenicon, Inc.2019-03-14GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00877972002772PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00877972002772008779720027728779720027720877972002772

GMDN Terms#

Term, Definition table
TermDefinition
Surgical irrigation/aspiration cannula, non-illuminating, reusableAn atraumatic, invasive, hand-operated tube designed as a conduit for irrigation and aspiration (i.e., capable of both functions) of body cavities/wounds during a surgical procedure (e.g., neurosurgery, laparoscopy), typically to facilitate observation. It is not dedicated to dental or intrauterine procedures, not an ophthalmic device, and is not designed to administer parenteral fluids or drugs. It might incorporate a handle with a valve(s) and hole(s) on its side for the control of irrigation/aspiration, and may be provided with a stylet, a sheath, and/or connection tubing; it is typically made of metal. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
079805400
Device count
1
Serial number
true
Manufacturing date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00877972006718X-Surge590-005-0132019-11-14
00877972001980GeniSurge533-005-9052017-05-05
00877972001997GeniSurge533-005-9102017-05-05
00877972002000GeniSurge533-005-9152017-05-05
00877972002017GeniSurge533-005-9202017-05-05
00877972002154GeniSurge533-005-9252017-05-05
00877972002161GeniSurge533-005-9302017-05-05
00877972002178GeniSurge533-005-9352017-05-05
00877972002185GeniSurge533-005-9402017-05-05
00877972002192GeniSurge533-005-9452017-05-05
00877972002208GeniSurge533-005-9502017-05-05
00877972004615GeniSurge533-105-9102017-05-05
00877972005957NanoSurge528-063-9102017-05-05
00877972005971NanoSurge528-063-9202017-05-05
00877972005995NanoSurge528-063-9452017-05-05
00877972006015NanoSurge528-063-9502017-05-05
00877972006190NanoSurge520-063-9102017-05-05
00877972006213NanoSurge520-063-9202017-05-05
00877972006237NanoSurge520-063-9452017-05-05
00877972006251NanoSurge520-063-9502017-05-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776422745MillenniumAvalign Technologies, Inc.GCJ2026-08-03
00190776422752MillenniumAvalign Technologies, Inc.GCJ2026-08-03
04026704934812TELEFLEXTELEFLEX INCORPORATEDGCJ2026-08-03
B382SD4131490Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
B382SD4162910Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
B382SD49245120Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
B382SD55670280Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
B382SD56325330Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
B382SD56400150Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
B382SD56534210Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
B382SD567910130Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
B382SD56914330Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
00190776421960MillenniumAvalign Technologies, Inc.GCJ2026-07-31
00190776422325MillenniumAvalign Technologies, Inc.GCJ2026-07-31
00888867498105Arthrex®ARTHREX, INC.GCJ2026-07-31
14026704921741TELEFLEXTELEFLEX INCORPORATEDGCJ2026-07-31
B382SD13768130Surgical DirectSurgical Direct, Inc.GCJ2026-07-31
B382SD13798130Surgical DirectSurgical Direct, Inc.GCJ2026-07-31
B382SD14678780Surgical DirectSurgical Direct, Inc.GCJ2026-07-31
B382SD15378970Surgical DirectSurgical Direct, Inc.GCJ2026-07-31
B382SD15458990Surgical DirectSurgical Direct, Inc.GCJ2026-07-31
B382SD161090Surgical DirectSurgical Direct, Inc.GCJ2026-07-31
B382SD169920Surgical DirectSurgical Direct, Inc.GCJ2026-07-31
B382SD30109760Surgical DirectSurgical Direct, Inc.GCJ2026-07-31
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