FDA.report

Gen2

Primary DI
00840343700928
Brand
Gen2
Company
SURGIX MEDICAL LLC
Model
G2E900957
Catalog number
G2E900957
Device description
HOUSE SICKLE KNIFE
Published
2022-10-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
KTGKnife, Ent

Product Code Classifications

CodeDeviceSpecialtyClass
KTGKnife, EntEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
G277G2E9009570PreviousHIBCC0
00840343700928PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840343700928008403437009288403437009280840343700928

GMDN Terms

TermDefinition
Towel clamp, reusableA surgical instrument designed to hold together surgical towels and/or drapes, or for securing other devices such as cables/leads, during an operation/intervention. It is made of metallic or polymer materials and is available in a variety of sizes and designs (e.g., two blades joined at their midpoints, single alpha-shaped device, various gripping jaws); it is commonly known as a towel clamp, towel forceps, or towel clip. This is a reusable device.

Device Sizes

TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Length190Millimeter

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
888-247-0477customerservice@surgixmedical.com

Regulatory Flags

DUNS number
080402644
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

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00840343726898GEN2G2NHX28085G2NHX280852025-09-11
00840343726904GEN2G2NHX29085G2NHX290852025-09-11
00840343726911GEN2G2NHX29045G2NHX290452025-09-11
00840343726928GEN2G2NHX29055G2NHX290552025-09-11
00840343726935GEN2G2NHX29065G2NHX290652025-09-11
00840343726942GEN2G2G21340G2G213402025-09-11
00840343726621GEN2G2N11074G2N110742025-08-05
00840343726645GEN233501-41-00033501-41-0002025-08-05
00840343726652GEN2G2G36083 G2G36083 2025-08-05
00840343726669GEN2G2N81430G2N81430 2025-08-05
00840343726676GEN2G2N81420G2N81420 2025-08-05
00840343726683GEN2G2N81431G2N814312025-08-05
00840343726690GEN2G2N81421G2N814212025-08-05
00840343726706GEN2G2N81433G2N814332025-08-05
00840343726713GEN2G2N81423G2N814232025-08-05
00840343726584GEN2G2G12090G2G120902025-07-09
00840343726591GEN2G2N48721TCG2N48721TC2025-07-09
00840343726607GEN2G2N99514G2N995142025-07-09
00840343726614GEN2G2N99515G2N995152025-07-09

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00757770429301Bausch + LombBausch & Lomb IncorporatedKTG2026-02-04
04250381870433SeparatorSpiggle & Theis Medizintechnik GmbHKTG2025-09-19
04250676723192Sickle knifeSpiggle & Theis Medizintechnik GmbHKTG2025-09-15
04250676735072KnifeSpiggle & Theis Medizintechnik GmbHKTG2025-09-15
04250676718600Rosen round knifeSpiggle & Theis Medizintechnik GmbHKTG2025-09-12
04250676740595Teschner sickle knifeSpiggle & Theis Medizintechnik GmbHKTG2025-09-11
04250676741790Rosen round knifeSpiggle & Theis Medizintechnik GmbHKTG2025-09-11
00190776409371MillenniumAvalign Technologies, Inc.KTG2025-08-28
00190776409388MillenniumAvalign Technologies, Inc.KTG2025-08-28
00194613056377MSI Precision Specialty InstrumentsMed Saver, Inc.KTG2025-08-01
00194613056407MSI Precision Specialty InstrumentsMed Saver, Inc.KTG2025-08-01
00194613102609MSI Precision Specialty InstrumentsMed Saver, Inc.KTG2025-08-01
00194613108700MSI Precision Specialty InstrumentsMed Saver, Inc.KTG2025-08-01
00194613108762MSI Precision Specialty InstrumentsMed Saver, Inc.KTG2025-08-01
00194613118037MSI Precision Specialty InstrumentsMed Saver, Inc.KTG2025-08-01
00194613119621MSI Precision Specialty InstrumentsMed Saver, Inc.KTG2025-08-01
00757770422234Bausch + LombBausch & Lomb IncorporatedKTG2025-07-29
00757770423699Bausch + LombBausch & Lomb IncorporatedKTG2025-07-29
00190776406615MillenniumAvalign Technologies, Inc.KTG2025-07-23
00190776405694MillenniumAvalign Technologies, Inc.KTG2025-07-18
00190776397647MillenniumAvalign Technologies, Inc.KTG2025-05-16
00194613047504MSI Precision Specialty InstrumentsMed Saver, Inc.KTG2025-03-21
00194613056353MSI Precision Specialty InstrumentsMed Saver, Inc.KTG2025-03-21
00194613056360MSI Precision Specialty InstrumentsMed Saver, Inc.KTG2025-03-21
00194613056391MSI Precision Specialty InstrumentsMed Saver, Inc.KTG2025-03-21
00194613107734MSI Precision Specialty InstrumentsMed Saver, Inc.KTG2025-03-21
00194613108625MSI Precision Specialty InstrumentsMed Saver, Inc.KTG2025-03-21
00194613109226MSI Precision Specialty InstrumentsMed Saver, Inc.KTG2025-03-21
G141546380150Carnegie Surgical LLCCarnegie Surgical LLCKTG2025-02-03
00840183529284BR Surgical, LLCBR Surgical, LLCKTG2025-01-03