FDA.reportPublic FDA data

GEN2

Primary DI
G277G2N648530
Brand
GEN2
Company
SURGIX MEDICAL LLC
Model
G2N64853
Catalog number
G2N64853
Device description
"MICRO EJECTOR KERRISON, PIN TYPE 40D UP 8"" 3MM"
Published
2022-09-27
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
HAERongeur, Manual

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HAERongeur, ManualNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G277G2N648530PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic joint/limb rongeurA hand-held manual surgical instrument designed to remove bone during an orthopaedic intervention of the limbs/joints; it is not primarily intended for nasal, spinal, or cranial use and is not a dedicated rib rongeur. It is a heavy-duty metallic instrument that has a forceps- or pliers-like design and terminates at the distal end with sharp-edged, scoop-shaped jaws attached to strong, sprung (self-opening), pivoted or multi-pivoted handles that, when squeezed together, close the jaws to bite (cut) through the bone. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
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
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
00190776397128MillenniumAvalign Technologies, Inc.HAE2026-07-16
00190776395520MillenniumAvalign Technologies, Inc.HAE2026-07-14
04255968300020VitalitecVitalitec International Medizintechnik GmbHHAE2026-06-23
07613327651676mild Device KitSTRYKER CORPORATIONHAE2024-11-22
B235MDK00020mild Device KitSTRYKER CORPORATIONHAE2024-06-19
G277G2N732330GEN2SURGIX MEDICAL LLCHAE2022-09-28
04046955074624AESCULAPAESCULAP, INC.HAE2019-04-30
04046955074631AESCULAPAESCULAP, INC.HAE2019-04-30
04046955074648AESCULAPAESCULAP, INC.HAE2019-04-30
04046955074655AESCULAPAESCULAP, INC.HAE2019-04-30
04046955074662AESCULAPAESCULAP, INC.HAE2019-04-30
04046955074716AESCULAPAESCULAP, INC.HAE2019-04-30
04046955074723AESCULAPAESCULAP, INC.HAE2019-04-30
04046955074730AESCULAPAESCULAP, INC.HAE2019-04-30
04046955074792AESCULAPAESCULAP, INC.HAE2019-04-30
04046955074808AESCULAPAESCULAP, INC.HAE2019-04-30
04046955074815AESCULAPAESCULAP, INC.HAE2019-04-30
04046955074822AESCULAPAESCULAP, INC.HAE2019-04-30
04046955074914AESCULAPAESCULAP, INC.HAE2019-04-30
04046955074921AESCULAPAESCULAP, INC.HAE2019-04-30
04046955074938AESCULAPAESCULAP, INC.HAE2019-04-30
04046955074945AESCULAPAESCULAP, INC.HAE2019-04-30
04046955074952AESCULAPAESCULAP, INC.HAE2019-04-30
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