FDA.reportPublic FDA data

Gen2

Primary DI
G277G2E166600
Brand
Gen2
Company
SURGIX MEDICAL LLC
Model
G2E16660
Catalog number
G2E16660
Device description
HOUSE GELFOAM PRESS 12x15mm PL
Published
2022-09-22
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
LRCInstrument, Ent Manual Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRCInstrument, Ent Manual SurgicalEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G277G2E166600PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Gelfoam punchA manual instrument designed to punch circles of various sizes from a piece of Gelfoam (a sterile compressed gelatin sponge having haemostatic properties which usually absorbs completely within four to six weeks) typically used to help construct ossicular replacements during middle ear surgery. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Length15Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
888-247-2477customerservice@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
04250676750815Lucae cerumen hookSpiggle & Theis Medizintechnik GmbHLRC2026-10-28
04250676750822Lucae cerumen hookSpiggle & Theis Medizintechnik GmbHLRC2026-10-28
04250676750839Lucae cerumen hookSpiggle & Theis Medizintechnik GmbHLRC2026-10-28
04250676750891Billeau ear loopSpiggle & Theis Medizintechnik GmbHLRC2026-10-28
04250676750907Billeau ear loopSpiggle & Theis Medizintechnik GmbHLRC2026-10-28
04250676750914Billeau ear loopSpiggle & Theis Medizintechnik GmbHLRC2026-10-28
04250676750921Snellen ear loopSpiggle & Theis Medizintechnik GmbHLRC2026-10-28
04250676750938Snellen ear loopSpiggle & Theis Medizintechnik GmbHLRC2026-10-28
B382SD67371410Surgical DirectSurgical Direct, Inc.LRC2026-10-28
B382SD9114681000Surgical DirectSurgical Direct, Inc.LRC2026-10-28
00190776423070MillenniumAvalign Technologies, Inc.LRC2026-10-21
00190776435813MillenniumAvalign Technologies, Inc.LRC2026-10-21
00190776435820MillenniumAvalign Technologies, Inc.LRC2026-10-21
00190776435837MillenniumAvalign Technologies, Inc.LRC2026-10-21
00190776435844MillenniumAvalign Technologies, Inc.LRC2026-10-21
00190776435851MillenniumAvalign Technologies, Inc.LRC2026-10-21
00190776435868MillenniumAvalign Technologies, Inc.LRC2026-10-21
00190776436735MillenniumAvalign Technologies, Inc.LRC2026-10-21
00190776436742MillenniumAvalign Technologies, Inc.LRC2026-10-21
00190776436759MillenniumAvalign Technologies, Inc.LRC2026-10-21
00190776435417MillenniumAvalign Technologies, Inc.LRC2026-10-19
00190776434946MillenniumAvalign Technologies, Inc.LRC2026-10-14
00190776434977MillenniumAvalign Technologies, Inc.LRC2026-10-14
00190776434618MillenniumAvalign Technologies, Inc.LRC2026-10-09
00198506095795ELMED INCORPORATEDELMED INCORPORATEDLRC2026-10-09
00190776433529MillenniumAvalign Technologies, Inc.LRC2026-10-06
00192896123854Gum ScissorsSONTEC INSTRUMENTS, INC.LRC2026-10-06
00190776433093MillenniumAvalign Technologies, Inc.LRC2026-10-01
00190776432539MillenniumAvalign Technologies, Inc.LRC2026-09-28
00190776432263MillenniumAvalign Technologies, Inc.LRC2026-09-24