FDA.reportPublic FDA data

GEN2

Primary DI
00840343727345
Brand
GEN2
Company
SURGIX MEDICAL LLC
Model
G2N88855
Catalog number
G2N88855
Device description
BAYONET CERVICAL MICRO NERVE HOOK, BLACK HANDLE, 8.5''
Published
2026-04-16
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
GDGHook, Surgical, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDGHook, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840343727345PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840343727345008403437273458403437273450840343727345

GMDN Terms#

Term, Definition table
TermDefinition
Soft-tissue surgical hook, reusableA hand-held, shaft-like, manual surgical instrument designed for hooking and applying traction to specific soft-tissues of interest (e.g., skin, vessel, organ, and/or duct), to facilitate surgical intervention; it is not dedicated to separating or drawing aside the margins of a surgical wound/incision (i.e., not a blade-style retractor). The device includes a handle and tapers towards the distal end to form a slender hook/parallel hooks. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length8.5Inch

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
00724995267896Snowden-PencerSTERIS Deutschland GmbHGDG2026-09-25
00190776432379MillenniumAvalign Technologies, Inc.GDG2026-09-24
00190776432423MillenniumAvalign Technologies, Inc.GDG2026-09-24
00724995267483Snowden-PencerSTERIS Deutschland GmbHGDG2026-09-24
00724995267490Snowden-PencerSTERIS Deutschland GmbHGDG2026-09-24
00724995267506Snowden-PencerSTERIS Deutschland GmbHGDG2026-09-24
00724995267513Snowden-PencerSTERIS Deutschland GmbHGDG2026-09-24
00724995267520Snowden-PencerSTERIS Deutschland GmbHGDG2026-09-24
00724995267544Snowden-PencerSTERIS Deutschland GmbHGDG2026-09-24
00724995267551Snowden-PencerSTERIS Deutschland GmbHGDG2026-09-24
00724995267568Snowden-PencerSTERIS Deutschland GmbHGDG2026-09-24
00724995267575Snowden-PencerSTERIS Deutschland GmbHGDG2026-09-24
00724995267582Snowden-PencerSTERIS Deutschland GmbHGDG2026-09-24
00724995267599Snowden-PencerSTERIS Deutschland GmbHGDG2026-09-24
00724995267605Snowden-PencerSTERIS Deutschland GmbHGDG2026-09-24
00724995267612Snowden-PencerSTERIS Deutschland GmbHGDG2026-09-24
00724995267629Snowden-PencerSTERIS Deutschland GmbHGDG2026-09-24
00850088713954PRINCETONPrinceton Medical Group, Inc.GDG2026-09-22
00190776431099MillenniumAvalign Technologies, Inc.GDG2026-09-21
B033K941409" Nerve HookKapp Surgical Instrument Co.GDG2026-08-27
00810158215955PRINCETONPrinceton Medical Group, Inc.GDG2026-08-25
10850067560323MaxRetractSurgical Principals, IncGDG2026-08-25
10850067560330MaxRetractSurgical Principals, IncGDG2026-08-25
10850067560347MaxRetractSurgical Principals, IncGDG2026-08-25
00190776419660MillenniumAvalign Technologies, Inc.GDG2026-08-23
00190776417161MillenniumAvalign Technologies, Inc.GDG2026-08-19
00190776417079MillenniumAvalign Technologies, Inc.GDG2026-08-18
00190776422219MillenniumAvalign Technologies, Inc.GDG2026-07-31
00190776407346MillenniumAvalign Technologies, Inc.GDG2026-07-28
B382SD907072080Surgical DirectSurgical Direct, Inc.GDG2026-07-27