FDA.reportPublic FDA data

GEN2

Primary DI
G277G2N732330
Brand
GEN2
Company
SURGIX MEDICAL LLC
Model
G2N73233
Catalog number
G2N73233
Device description
"LOVE-GRUENWALD IVD 3 X 10MM 12"" DOWN"
Published
2022-09-28
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
G277G2N732330PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Spinal rongeurA hand-held manual surgical instrument with sharp, scoop-shaped jaws designed for cutting tough tissues (intervertebral disk) or bone, through a cutting/biting action, during open spinal surgery (e.g., laminectomy, discectomy). It is typically made of metal and designed to withstand the forces required to bite over tough tissue. It is not intended for endoscopic access. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Length12Inch

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
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04255968301959VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-22
04255968301966VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-22
04255968301973VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-22