FDA.reportPublic FDA data

Gen2

Primary DI
G277G2G359680
Brand
Gen2
Company
SURGIX MEDICAL LLC
Model
G2G35968
Catalog number
G2G35968
Device description
"MCCULLOCH ANGLED BALL TIP PROBE 4MM 9 1/2"" (24CM)"
Published
2022-09-26
Public version status
Update
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
HXBProbe

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDGHook, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1
HXBProbeOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G277G2G359680PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Neurosurgical probeA non-sterile, slender, rod-like, hand-held manual surgical instrument, typically made of metal, with an angled tip and a handle, designed for exploring/dissecting intracranial structures during a surgical procedure (e.g., tumour removal, third ventriculostomy, cyst fenestration). This is a reusable device intended to be sterilized prior to use.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length4.5Inch

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
07640221373045PERLA ® TLSpineArt SAHXB2026-05-07
08800017271095ProbeCorentec Co., LtdHXB2026-04-10
09348811019622INKAThe Trustee for KAISER FAMILY TRUSTGDG2025-11-21
09348811019639INKAThe Trustee for KAISER FAMILY TRUSTGDG2025-11-21
07640177820631Neo Medical Pedicle Screw SystemNeo Medical SAHXB2023-01-26
07898506815241QuinelatoSchobell Industrial LtdaHXB2023-01-09
07899798204461SchobellSchobell Industrial LtdaHXB2022-12-16
G079C5020010040Golden Isles Pedicle Screw SystemIntelivation, LLCHXB2022-10-26
10381780503194Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGDG2019-02-19
10381780503200Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGDG2019-02-19
10381780503729Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGDG2019-02-19
10381780503736Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGDG2019-02-19
10381780503798Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGDG2019-02-19
10381780503804Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGDG2019-02-19
10381780449195Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGDG2018-12-19
10381780495833Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGDG2018-10-24
10381780498681Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGDG2018-09-18
10381780498698Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGDG2018-09-18
10381780498704Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGDG2018-09-18
10381780490418Integra® MicroFrance®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGDG2018-09-14
10381780218135Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGDG2018-09-12
10381780229827Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGDG2018-09-12
10381780487593Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGDG2018-08-20
10381780487852Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGDG2018-08-20
10381780487869Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGDG2018-08-20
10381780487876Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGDG2018-08-20
10381780487883Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGDG2018-08-20
10381780487890Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGDG2018-08-20
10381780487968Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGDG2018-08-20
10381780487975Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGDG2018-08-20