FDA.reportPublic FDA data

GEN2

Primary DI
00840343722838
Brand
GEN2
Company
SURGIX MEDICAL LLC
Model
G2G1828
Catalog number
G2G1828
Device description
T-C STRABISMUS SCISSORS, 4-1/2'', STR
Published
2024-06-28
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
LRWScissors, General, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRWScissors, General, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840343722838PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840343722838008403437228388403437228380840343722838

GMDN Terms#

Term, Definition table
TermDefinition
Surgical soft-tissue manipulation forceps, tweezers-like, reusableA hand-held, manual, open-surgery instrument designed to facilitate grasping and manipulation of soft-tissues. It has a tweezers-like design (may be a micro/fine instrument) with variously designed tips at the working end, whereby the blades are designed to be opened/closed by squeezing between the fingers (i.e., without ring handles). It is made of high-grade stainless steel, available in various sizes, and may have carbide inserts at the working end. It is not an electrosurgical device and not dedicated to ophthalmic surgery. This is a reusable device intended to be sterilized prior to use.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length4.5Inch

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
00810055250547Surgical DesignSurgical Design, Inc.LRW2026-05-26
00810055256211Surgical DesignSurgical Design, Inc.LRW2026-05-26
00810055256235Surgical DesignSurgical Design, Inc.LRW2026-05-26
00810055256242Surgical DesignSurgical Design, Inc.LRW2026-05-26
00810055256259Surgical DesignSurgical Design, Inc.LRW2026-05-26
00810055258604Surgical DesignSurgical Design, Inc.LRW2026-05-26
00810055258611Surgical DesignSurgical Design, Inc.LRW2026-05-26
00810055258628Surgical DesignSurgical Design, Inc.LRW2026-05-26
00810055258635Surgical DesignSurgical Design, Inc.LRW2026-05-26
00810055258642Surgical DesignSurgical Design, Inc.LRW2026-05-26
00810055258659Surgical DesignSurgical Design, Inc.LRW2026-05-26
00810055258666Surgical DesignSurgical Design, Inc.LRW2026-05-26
00810055258673Surgical DesignSurgical Design, Inc.LRW2026-05-26
00810055258680Surgical DesignSurgical Design, Inc.LRW2026-05-26
00810055258697Surgical DesignSurgical Design, Inc.LRW2026-05-26
00810055258703Surgical DesignSurgical Design, Inc.LRW2026-05-26
00810055258710Surgical DesignSurgical Design, Inc.LRW2026-05-26
00810055258727Surgical DesignSurgical Design, Inc.LRW2026-05-26
00810220800218Adler Instrument CompanyAdler, Inc.LRW2026-05-26
00810220800225Adler Instrument CompanyAdler, Inc.LRW2026-05-26
00810220800232Adler Instrument CompanyAdler, Inc.LRW2026-05-26
00810055250455Surgical DesignSurgical Design, Inc.LRW2026-05-25
00810055250462Surgical DesignSurgical Design, Inc.LRW2026-05-25
00810055250479Surgical DesignSurgical Design, Inc.LRW2026-05-25
00810055250486Surgical DesignSurgical Design, Inc.LRW2026-05-25
00810055250493Surgical DesignSurgical Design, Inc.LRW2026-05-25
00810055250509Surgical DesignSurgical Design, Inc.LRW2026-05-25
00810055250516Surgical DesignSurgical Design, Inc.LRW2026-05-25
00810055250523Surgical DesignSurgical Design, Inc.LRW2026-05-25
00810055250554Surgical DesignSurgical Design, Inc.LRW2026-05-25