FDA.reportPublic FDA data

GEN2

Primary DI
00840343727284
Brand
GEN2
Company
SURGIX MEDICAL LLC
Model
G2N99740
Catalog number
G2N99740
Device description
Micro Kerrison, bayonet, 5mm, 40° up 15cm working length SHARP COATED
Published
2026-04-14
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
00840343727284PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840343727284008403437272848403437272840840343727284

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
Device Size Text, specify0

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
00724995311759V. MuellerSTERIS Deutschland GmbHHAE2026-09-25
00724995311766V. MuellerSTERIS Deutschland GmbHHAE2026-09-25
00724995311865V. MuellerSTERIS Deutschland GmbHHAE2026-09-25
00724995311872V. MuellerSTERIS Deutschland GmbHHAE2026-09-25
00724995311889V. MuellerSTERIS Deutschland GmbHHAE2026-09-25
00724995311964V. MuellerSTERIS Deutschland GmbHHAE2026-09-25
00724995311971V. MuellerSTERIS Deutschland GmbHHAE2026-09-25
00724995311988V. MuellerSTERIS Deutschland GmbHHAE2026-09-25
00724995311995V. MuellerSTERIS Deutschland GmbHHAE2026-09-25
00724995312008V. MuellerSTERIS Deutschland GmbHHAE2026-09-25
00724995312015V. MuellerSTERIS Deutschland GmbHHAE2026-09-25
00724995312077V. MuellerSTERIS Deutschland GmbHHAE2026-09-25
00724995312084V. MuellerSTERIS Deutschland GmbHHAE2026-09-25
00724995312091V. MuellerSTERIS Deutschland GmbHHAE2026-09-25
00724995312107V. MuellerSTERIS Deutschland GmbHHAE2026-09-25
00190776432331MillenniumAvalign Technologies, Inc.HAE2026-09-24
04250325493537VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-22
04255968301713VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-22
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04255968301843VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-22
04255968301850VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-22
04255968301867VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-22
04255968301874VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-22
04255968301959VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-22
04255968301966VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-22
04255968301973VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-22