FDA.reportPublic FDA data

GEN2

Primary DI
00840343700553
Brand
GEN2
Company
SURGIX MEDICAL LLC
Model
G2E900958
Catalog number
G2E900958
Device description
HOUSE SEPARATOR BAYONET 1.5MM
Published
2022-10-18
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
GENForceps, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GENForceps, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G277G2E9009580PreviousHIBCC0
00840343700553PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840343700553008403437005538403437005530840343700553

GMDN Terms#

Term, Definition table
TermDefinition
Ear excavatorA hand-held manual surgical instrument designed for cutting, scraping, scooping and removing tissue during a surgical procedure in or around the ear, allowing the performance of specialized procedures such as removal of the cochlear cupola and microsurgery of the middle ear and the sinus timpani. It is made of high-grade stainless steel and typically designed as a double-ended instrument having a central handle with small and sharp spoon-, scoop-, or spatula-shaped blades that have cutting/gouging edges. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length6.75Inch

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
G043201100BEARBear-Ent, LLCGEN2026-04-17
G043201130BEARBear-Ent, LLCGEN2026-04-17
G043201140BEARBear-Ent, LLCGEN2026-04-17
G043201160BEARBear-Ent, LLCGEN2026-04-17
G043201190BEARBear-Ent, LLCGEN2026-04-17
G043201200BEARBear-Ent, LLCGEN2026-04-17
09348811008756INKAThe Trustee for KAISER FAMILY TRUSTGEN2025-11-19
09348811009029INKAThe Trustee for KAISER FAMILY TRUSTGEN2025-11-19
09348811009050INKAThe Trustee for KAISER FAMILY TRUSTGEN2025-11-19
09348811009135INKAThe Trustee for KAISER FAMILY TRUSTGEN2025-11-19
09348811010155INKAThe Trustee for KAISER FAMILY TRUSTGEN2025-11-19
09348811151162INKAThe Trustee for KAISER FAMILY TRUSTGEN2025-11-19
G586D75480250NovosurgicalNOVO SURGICAL, INC.GEN2024-12-30
KTS1017012K.T.SurgicoK.T.SURGICOGEN2024-02-20
KTS1018012K.T.SurgicoK.T.SURGICOGEN2024-02-20
KTS1222112K.T.SurgicoK.T.SURGICOGEN2024-02-20
GYNX32071GynexGYNEX CORPORATIONGEN2023-12-26
07898506812424QuinelatoSchobell Industrial LtdaGEN2023-01-10
07898506812479QuinelatoSchobell Industrial LtdaGEN2023-01-10
07898506812516QuinelatoSchobell Industrial LtdaGEN2023-01-10
07898506812639QuinelatoSchobell Industrial LtdaGEN2023-01-10
07898506812646QuinelatoSchobell Industrial LtdaGEN2023-01-10
07898506812691QuinelatoSchobell Industrial LtdaGEN2023-01-10
07898506812769QuinelatoSchobell Industrial LtdaGEN2023-01-10
07898506812806QuinelatoSchobell Industrial LtdaGEN2023-01-10
07898506812813QuinelatoSchobell Industrial LtdaGEN2023-01-10
07898506813803QuinelatoSchobell Industrial LtdaGEN2023-01-10
07898506813810QuinelatoSchobell Industrial LtdaGEN2023-01-10
07898506850198QuinelatoSchobell Industrial LtdaGEN2023-01-10
07898506852772QuinelatoSchobell Industrial LtdaGEN2023-01-10