FDA.reportPublic FDA data

Gen2

Primary DI
00840343700430
Brand
Gen2
Company
SURGIX MEDICAL LLC
Model
G2E17517
Catalog number
G2E17517
Device description
HOUSE OVAL WINDOW PICK, 0.33mm
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
JYTPick, Microsurgical Ear

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JYTPick, Microsurgical EarEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G277G2E175170PreviousHIBCC0
00840343700430PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840343700430008403437004308403437004300840343700430

GMDN Terms#

Term, Definition table
TermDefinition
Middle ear pickA fine, hand-held manual surgical instrument intended to be used to manipulate the structures of the middle ear (e.g., the stapes). It is typically comprised of a proximal handle that tapers to a shaft which terminates in a fine distal tip bent at 90 degrees to the shaft. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
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
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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840343727178GEN2G2N99727G2N997272025-12-11
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 DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09348811111906INKAThe Trustee for KAISER FAMILY TRUSTJYT2026-03-16
09348811112002INKAThe Trustee for KAISER FAMILY TRUSTJYT2026-03-16
09348811150288INKAThe Trustee for KAISER FAMILY TRUSTJYT2026-03-09
09348811150356INKAThe Trustee for KAISER FAMILY TRUSTJYT2026-03-09
00757770682539Bausch + LombBausch & Lomb IncorporatedJYT2026-02-11
00757770714049Bausch + LombBausch & Lomb IncorporatedJYT2026-02-11
09348811112040INKAThe Trustee for KAISER FAMILY TRUSTJYT2025-12-02
00757770688531Bausch + LombBausch & Lomb IncorporatedJYT2025-11-14
00757770406821Bausch + LombBausch & Lomb IncorporatedJYT2025-08-05
00757770407613Bausch + LombBausch & Lomb IncorporatedJYT2025-08-05
00757770404346Bausch + LombBausch & Lomb IncorporatedJYT2025-08-04
00757770405725Bausch + LombBausch & Lomb IncorporatedJYT2025-08-04
00757770407644Bausch + LombBausch & Lomb IncorporatedJYT2025-08-04
00757770407774Bausch + LombBausch & Lomb IncorporatedJYT2025-08-04
00757770413157Bausch + LombBausch & Lomb IncorporatedJYT2025-08-04
00757770414628Bausch + LombBausch & Lomb IncorporatedJYT2025-08-04
00757770416158Bausch + LombBausch & Lomb IncorporatedJYT2025-08-04
00757770417025Bausch + LombBausch & Lomb IncorporatedJYT2025-08-04
00757770417681Bausch + LombBausch & Lomb IncorporatedJYT2025-08-04
00757770418190Bausch + LombBausch & Lomb IncorporatedJYT2025-08-04
00757770424856Bausch + LombBausch & Lomb IncorporatedJYT2025-08-04
00757770425273Bausch + LombBausch & Lomb IncorporatedJYT2025-08-04
00757770433520Bausch + LombBausch & Lomb IncorporatedJYT2025-08-04
00757770435425Bausch + LombBausch & Lomb IncorporatedJYT2025-08-04
00757770435883Bausch + LombBausch & Lomb IncorporatedJYT2025-08-04
00757770436613Bausch + LombBausch & Lomb IncorporatedJYT2025-08-04
00757770436651Bausch + LombBausch & Lomb IncorporatedJYT2025-08-04
00194613021733MSI Precision Specialty InstrumentsMed Saver, Inc.JYT2025-08-01
00194613021825MSI Precision Specialty InstrumentsMed Saver, Inc.JYT2025-08-01
00194613021832MSI Precision Specialty InstrumentsMed Saver, Inc.JYT2025-08-01