FDA.reportPublic FDA data

Gen2

Primary DI
00840343701505
Brand
Gen2
Company
SURGIX MEDICAL LLC
Model
G2G35968
Catalog number
G2G35968
Device description
MCCULLOCH ANGLED BALL TIP PROBE 4MM 9 1/2" (24CM)
Published
2022-10-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
G277G2G359680PreviousHIBCC0
00840343701505PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840343701505008403437015058403437015050840343701505

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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840343727178GEN2G2N99727G2N997272025-12-11
00840343726898GEN2G2NHX28085G2NHX280852025-09-11
00840343726904GEN2G2NHX29085G2NHX290852025-09-11
00840343726911GEN2G2NHX29045G2NHX290452025-09-11
00840343726928GEN2G2NHX29055G2NHX290552025-09-11
00840343726935GEN2G2NHX29065G2NHX290652025-09-11
00840343726942GEN2G2G21340G2G213402025-09-11
00840343726621GEN2G2N11074G2N110742025-08-05
00840343726645GEN233501-41-00033501-41-0002025-08-05
00840343726652GEN2G2G36083 G2G36083 2025-08-05
00840343726669GEN2G2N81430G2N81430 2025-08-05
00840343726676GEN2G2N81420G2N81420 2025-08-05
00840343726683GEN2G2N81431G2N814312025-08-05
00840343726690GEN2G2N81421G2N814212025-08-05
00840343726706GEN2G2N81433G2N814332025-08-05
00840343726713GEN2G2N81423G2N814232025-08-05
00840343726584GEN2G2G12090G2G120902025-07-09
00840343726591GEN2G2N48721TCG2N48721TC2025-07-09
00840343726607GEN2G2N99514G2N995142025-07-09
00840343726614GEN2G2N99515G2N995152025-07-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776417901MillenniumAvalign Technologies, Inc.GDG2026-03-23
00190776418335MillenniumAvalign Technologies, Inc.GDG2026-03-23
00190776418366MillenniumAvalign Technologies, Inc.GDG2026-03-23
00199150069675Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXB2026-03-20
04052536215522tezoUlrich GmbH & Co. KGGDG2026-03-16
00810158219328PRINCETONPrinceton Medical Group, Inc.GDG2026-03-12
00190776417826MillenniumAvalign Technologies, Inc.GDG2026-03-11
10705034577449N/AMedos International SàrlHXB2026-03-05
00190776417673MillenniumAvalign Technologies, Inc.GDG2026-03-04
10889981443436SpecialsSeaspine Orthopedics CorporationHXB2026-03-03
00190776417512MillenniumAvalign Technologies, Inc.GDG2026-02-27
00190776416775MillenniumAvalign Technologies, Inc.GDG2026-02-20
10888857578197Vulcan™ Spinal SystemK2M, INC.HXB2026-02-20
10888857578203Vulcan™ Spinal SystemK2M, INC.HXB2026-02-20
10888857578630Vulcan™ Spinal SystemK2M, INC.HXB2026-02-20
10888857578647Vulcan™ Spinal SystemK2M, INC.HXB2026-02-20
10888857578654Vulcan™ Spinal SystemK2M, INC.HXB2026-02-20
10888857578661Vulcan™ Spinal SystemK2M, INC.HXB2026-02-20
10888857578678Vulcan™ Spinal SystemK2M, INC.HXB2026-02-20
10888857578685Vulcan™ Spinal SystemK2M, INC.HXB2026-02-20
10888857578692Vulcan™ Spinal SystemK2M, INC.HXB2026-02-20
10888857578708Vulcan™ Spinal SystemK2M, INC.HXB2026-02-20
03662663131551Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHXB2026-02-11
03662663131568Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHXB2026-02-11
03662663131575Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHXB2026-02-11
03662663131582Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHXB2026-02-11
03662663131599Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHXB2026-02-11
03662663131605Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHXB2026-02-11
03662663131612Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHXB2026-02-11
00860014213458Introducer ProbeTETROUS, INC.HXB2026-02-10