FDA.reportPublic FDA data

GEN2

Primary DI
00840343713454
Brand
GEN2
Company
SURGIX MEDICAL LLC
Model
G2OB1527
Catalog number
G2OB1527
Device description
DESCHAMPS LIGATURE CARRIER RIGHT HAND 11"
Published
2022-11-04
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
GEJCarrier, Ligature

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEJCarrier, LigatureGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840343713454PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840343713454008403437134548403437134540840343713454

GMDN Terms#

Term, Definition table
TermDefinition
Surgical bulldog clamp, reusableA manual surgical instrument designed to grasp, join, compress or support an organ, vessel or soft-tissue. It has a flat, pincer-like design with self-retaining jaws that open upon squeezing of the handles and close upon release; it is typically made of high-grade stainless steel. It is commonly used for vascular clamping and is not dedicated to a specific type of non-vascular surgery. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length11Inch

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
00194613014438MSI Precision Specialty InstrumentsMed Saver, Inc.GEJ2025-08-01
00194613063443MSI Precision Specialty InstrumentsMed Saver, Inc.GEJ2024-08-15
00194613091439MSI Precision Specialty InstrumentsMed Saver, Inc.GEJ2024-08-15
00194613091484MSI Precision Specialty InstrumentsMed Saver, Inc.GEJ2024-08-15
00887482041444Symmetry Surgical®SYMMETRY SURGICAL INC.GEJ2024-08-15
00887482041451Symmetry Surgical®SYMMETRY SURGICAL INC.GEJ2024-08-15
00887482054918Symmetry SurgicalSYMMETRY SURGICAL INC.GEJ2024-08-15
00887482054925Symmetry Surgical®SYMMETRY SURGICAL INC.GEJ2024-08-15
00854037007170eXact Suture Placement DeviceCypris Medical, Inc.GEJ2024-06-10
00190776382711MillenniumAvalign Technologies, Inc.GEJ2024-05-06
00888515204522BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.GEJ2024-02-28
00888515204539BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.GEJ2024-02-28
00888515204591BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.GEJ2024-02-28
00888515204607BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.GEJ2024-02-28
G586UR6208140Novo SurgicalNOVO SURGICAL, INC.GEJ2023-12-18
G586UR96208140Novo SurgicalNOVO SURGICAL, INC.GEJ2023-12-18
00190776262549AvalignAvalign Technologies, Inc.GEJ2023-09-28
00840319750018Hayden MedicalHayden Medical, Inc.GEJ2023-03-21
00854037007149eXact 5.1Cypris Medical, Inc.GEJ2023-02-28
54026704788748PILLINGTELEFLEX INCORPORATEDGEJ2022-12-08
54026704811026PILLINGTELEFLEX INCORPORATEDGEJ2022-12-08
10885403133237V. MuellerCAREFUSION 2200, INCGEJ2022-11-27
00840306808111Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.GEJ2022-11-21
00840306808142Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.GEJ2022-11-14
00840306808319Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.GEJ2022-11-10
00840306808104Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.GEJ2022-11-07
00840306808128Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.GEJ2022-11-07
00840306808135Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.GEJ2022-11-07
00840343713461GEN2SURGIX MEDICAL LLCGEJ2022-11-04
00840343700058Gen2SURGIX MEDICAL LLCGEJ2022-10-18