FDA.reportPublic FDA data

GEN2

Primary DI
00840343715687
Brand
GEN2
Company
SURGIX MEDICAL LLC
Model
G2E901073
Catalog number
G2E901073
Device description
"LEWIS SEPTUM FORCEPS 8"" STR"
Published
2023-01-25
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
KAEForceps, Ent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KAEForceps, EntEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840343715687PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840343715687008403437156878403437156870840343715687

GMDN Terms#

Term, Definition table
TermDefinition
ENT soft-tissue cutting forcepsA hand-held manual surgical instrument with a biting action intended to be used to punch/cut/excise soft-tissue during an ear/nose/throat (ENT) procedure [e.g., adenoidectomy, tonsillectomy, sinus surgery, septoplasty, and/or biopsy]. It is a metallic instrument with a distal mechanism designed to bite tissue when the handles are squeezed together; some types may be used endoscopically (e.g., through a laryngopharyngoscope), and may include an integrated fluid suction channel for improved surgical field viewing. It is not intended for cutting bone (i.e., not a rongeur). This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length8Inch

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
09348811103796INKAThe Trustee for KAISER FAMILY TRUSTKAE2026-04-24
09348811104236INKAThe Trustee for KAISER FAMILY TRUSTKAE2026-04-24
09348811104595INKAThe Trustee for KAISER FAMILY TRUSTKAE2026-04-24
09348811104908INKAThe Trustee for KAISER FAMILY TRUSTKAE2026-04-24
09348811104915INKAThe Trustee for KAISER FAMILY TRUSTKAE2026-04-24
09348811104953INKAThe Trustee for KAISER FAMILY TRUSTKAE2026-04-24
09348811105653INKAThe Trustee for KAISER FAMILY TRUSTKAE2026-04-24
09348811105707INKAThe Trustee for KAISER FAMILY TRUSTKAE2026-04-24
09348811172099INKAThe Trustee for KAISER FAMILY TRUSTKAE2026-04-24
09348811172112INKAThe Trustee for KAISER FAMILY TRUSTKAE2026-03-18
G04371902F0BEARBear-Ent, LLCKAE2026-02-12
09348811105400INKAThe Trustee for KAISER FAMILY TRUSTKAE2025-11-21
09348811129024INKAThe Trustee for KAISER FAMILY TRUSTKAE2025-11-19
08906039316018OSSEOUS Titanium-Stapes Prosthesis Handling ForcepsEON MEDITECH PRIVATE LIMITEDKAE2024-07-04
08906039316025OSSEOUS Fluoroplastic-Stapes Prosthesis Handling ForcepsEON MEDITECH PRIVATE LIMITEDKAE2024-07-04
08906039316032OSSEOUS Stapes Prosthesis Crimping ForcepsEON MEDITECH PRIVATE LIMITEDKAE2024-07-04
08906039316049OSSEOUS Tilley's Nasal Dressings Forceps EON MEDITECH PRIVATE LIMITEDKAE2024-07-04
08906039319699OSSEOUS Micro Alligator Ear ForcepesEON MEDITECH PRIVATE LIMITEDKAE2024-07-04
G586NS80152710Novo SurgicalNOVO SURGICAL, INC.KAE2024-02-22
07898506842704QuinelatoSchobell Industrial LtdaKAE2023-01-09
10381780406815Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKAE2018-08-16
10381780407072Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKAE2018-08-16
10381780402855Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKAE2018-05-03
10381780402862Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKAE2018-05-03
10381780402954Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKAE2018-05-03
10381780402961Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKAE2018-05-03
10381780402985Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKAE2018-05-03
10381780402992Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKAE2018-05-03
10381780403012Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKAE2018-05-03
10381780403036Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKAE2018-05-03