FDA.reportPublic FDA data

Gen2

Primary DI
00840343727475
Brand
Gen2
Company
SURGIX MEDICAL LLC
Model
G2G37279
Catalog number
G2G37279
Device description
"Brewster Retractor ""A"" OL 245mm (9 3/4""), TW 48mm, Tip Depth 64mm"
Published
2026-04-22
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
GADRetractor

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GADRetractorGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840343727475PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840343727475008403437274758403437274750840343727475

GMDN Terms#

Term, Definition table
TermDefinition
Hand-held surgical retractor, reusableA hand-held, non-self-retaining surgical instrument intended to be used to separate/draw aside the margins of a wound/incision to allow access to tissues/organs during open surgery; it is not dedicated to ophthalmic surgery or small nerve/vessel retraction, but may otherwise be clinically dedicated. It includes a shaped/hooked blade with a handle/holding portion and is available in a wide variety of designs, such as a double- or single-ended blade that may be fenestrated (pronged); deep wound retractors are typically designed with a long, curved blade that may also be intended to retract organs; it may include a light. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth64Millimeter
Device Size Text, specify0
Length9.75Inch

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
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
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
00840343727345GEN2G2N88855G2N888552026-04-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995266936Snowden-PencerSTERIS Deutschland GmbHGAD2026-10-15
00810130207572MSIModern Surgical Instruments LLCGAD2026-10-15
00810130207589MSIModern Surgical Instruments LLCGAD2026-10-15
00810220800645Adler Instrument CompanyAdler, Inc.GAD2026-10-15
00810220800652Adler Instrument CompanyAdler, Inc.GAD2026-10-15
00810220800669Adler Instrument CompanyAdler, Inc.GAD2026-10-15
03661219013341LANDANGERLANDANGERGAD2026-10-15
10724995269316Snowden-PencerSTERIS Deutschland GmbHGAD2026-10-15
10724995269323Snowden-PencerSTERIS Deutschland GmbHGAD2026-10-15
00190776434953MillenniumAvalign Technologies, Inc.GAD2026-10-14
00192896123922Knurled NutSONTEC INSTRUMENTS, INC.GAD2026-10-14
00842102116513DynaTrac Retractor FramesFLEXBAR MACHINE CORPORATIONGAD2026-10-14
00190776434632MillenniumAvalign Technologies, Inc.GAD2026-10-12
00190776434663MillenniumAvalign Technologies, Inc.GAD2026-10-12
00190776434700MillenniumAvalign Technologies, Inc.GAD2026-10-12
04058749044249NAFehling Instruments GmbH & Co. KGGAD2026-10-12
G1415189430Carnegie Surgical LLCCarnegie Surgical LLCGAD2026-10-12
00190776434144MillenniumAvalign Technologies, Inc.GAD2026-10-09
00190776434205MillenniumAvalign Technologies, Inc.GAD2026-10-09
00190776434212MillenniumAvalign Technologies, Inc.GAD2026-10-09
00190776434601MillenniumAvalign Technologies, Inc.GAD2026-10-09
00198506095849ELMED INCORPORATEDELMED INCORPORATEDGAD2026-10-09
00198506095856ELMED INCORPORATEDELMED INCORPORATEDGAD2026-10-09
00840277133717Innomed, Inc.INNOMED, INC.GAD2026-10-09
00840277133922Innomed, Inc.INNOMED, INC.GAD2026-10-09
00840277133939Innomed, Inc.INNOMED, INC.GAD2026-10-09
00840277133946Innomed, Inc.INNOMED, INC.GAD2026-10-09
00840277133953Innomed, Inc.INNOMED, INC.GAD2026-10-09
00840277133960Innomed, Inc.INNOMED, INC.GAD2026-10-09
00840277133977Innomed, Inc.INNOMED, INC.GAD2026-10-09