FDA.reportPublic FDA data

GEN2

Primary DI
00840343727208
Brand
GEN2
Company
SURGIX MEDICAL LLC
Model
G2NH29055
Catalog number
G2NH29055
Device description
"HOWINGTON SUCTION, 5FR Atraumatic Tip with Side holes, 5"" from the bend, 6"" O.A.L"
Published
2026-04-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JOLCatheter And Tip, Suction

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JOLCatheter And Tip, SuctionGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840343727208PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840343727208008403437272088403437272080840343727208

GMDN Terms#

Term, Definition table
TermDefinition
Surgical/emergency suction cannula, non-illuminating, reusableAn atraumatic, invasive, hand-operated, single-lumen, rigid/semi-rigid tube designed as a conduit for aspiration of body cavities, wounds, or surgical sites to facilitate observation and/or to clear an airway obstruction. It is not dedicated to dental, intrauterine, or liposuction procedures, and is neither an ophthalmic nor an intravascular device; it is not designed for surgical irrigation. Sometimes referred to as a suction tube or tip, it may incorporate a handle with side valve(s)/hole(s), and may be provided with a stylet, sheath, and/or connection tubing; it does not include a light source or fibreoptic bundle. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length6Inch

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
888-247-0477customerservice@surgixmedical.com

Regulatory Flags#

DUNS number
080402644
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840343727437Gen2G2N99753G2N997532026-04-23
00840343727567Gen2G2G37293G2G372932026-04-23
00840343727574Gen2G2N99755G2N997552026-04-23
00840343727581Gen2G2C62489G2C624892026-04-23
00840343727451Gen2G2N49254G2N492542026-04-22
00840343727468Gen2G2G37278G2G372782026-04-22
00840343727475Gen2G2G37279G2G372792026-04-22
00840343727482Gen2G2G35954G2G359542026-04-22
00840343727499Gen2G2C62277G2C622772026-04-22
00840343727505Gen2G2C62434G2C624342026-04-22
00840343727512Gen2G2N48672TCG2N48672TC2026-04-22
00840343727529Gen2G2N87457G2N874572026-04-22
00840343727536Gen2G2N99517G2N995172026-04-22
00840343727543Gen2G2G37282G2G372822026-04-22
00840343727550Gen2G2O917144G2O9171442026-04-22
00840343727291GEN2G2E901343G2E9013432026-04-16
00840343727307GEN2G2E901344G2E9013442026-04-16
00840343727314GEN2G2E901345G2E9013452026-04-16
00840343727321GEN2G2E900935G2E9009352026-04-16
00840343727338GEN2G2N52380G2N523802026-04-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B382SD911424030Surgical DirectSurgical Direct, Inc.JOL2026-07-23
B382SD911424050Surgical DirectSurgical Direct, Inc.JOL2026-07-23
B382SD911424060Surgical DirectSurgical Direct, Inc.JOL2026-07-23
B382SD9114241000Surgical DirectSurgical Direct, Inc.JOL2026-07-23
B382SD9114251000Surgical DirectSurgical Direct, Inc.JOL2026-07-23
B382SD91143009NC0Surgical DirectSurgical Direct, Inc.JOL2026-07-23
B382SD9114301120Surgical DirectSurgical Direct, Inc.JOL2026-07-23
B382SD91143012NC0Surgical DirectSurgical Direct, Inc.JOL2026-07-23
B382SD9114311010Surgical DirectSurgical Direct, Inc.JOL2026-07-23
B382SD9114311060Surgical DirectSurgical Direct, Inc.JOL2026-07-23
B382SD9114311080Surgical DirectSurgical Direct, Inc.JOL2026-07-23
B382SD911437070Surgical DirectSurgical Direct, Inc.JOL2026-07-23
B382SD91143709NC0Surgical DirectSurgical Direct, Inc.JOL2026-07-23
B382SD9114511000Surgical DirectSurgical Direct, Inc.JOL2026-07-23
B382SD911451123NC0Surgical DirectSurgical Direct, Inc.JOL2026-07-23
B382SD9114511310Surgical DirectSurgical Direct, Inc.JOL2026-07-23
B382SD91145114510Surgical DirectSurgical Direct, Inc.JOL2026-07-23
B382SD9114521010Surgical DirectSurgical Direct, Inc.JOL2026-07-23
B382SD9114521020Surgical DirectSurgical Direct, Inc.JOL2026-07-23
B382SD9114521030Surgical DirectSurgical Direct, Inc.JOL2026-07-23
00190776403959MillenniumAvalign Technologies, Inc.JOL2026-07-22
00190776403966MillenniumAvalign Technologies, Inc.JOL2026-07-22
00810220800492Adler Instrument CompanyAdler, Inc.JOL2026-07-17
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00846159040692SCANLAN Minimally-Invasive InstrumentationSCANLAN INTERNATIONAL INCJOL2026-07-17
00846159040708SCANLAN®SCANLAN INTERNATIONAL INCJOL2026-07-17
10888277407954MEDLINEMEDLINE INDUSTRIES, INC.JOL2026-07-17
04719874957568Create BiotechCREATE BIOTECH CO., LTD.JOL2026-07-16
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