FDA.reportPublic FDA data

GEN2

Primary DI
00840343724368
Brand
GEN2
Company
SURGIX MEDICAL LLC
Model
G2G19100
Catalog number
G2G19100
Device description
S-S DERF NEEDLE HOLDER 4-3/4''
Published
2024-10-23
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
FHQHolder, Needle, Gastroenterologic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FHQHolder, Needle, GastroenterologicGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840343724368PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840343724368008403437243688403437243680840343724368

GMDN Terms#

Term, Definition table
TermDefinition
Suturing needle holder, reusableA hand-held manual surgical instrument designed to grasp a suture needle when pushing/pulling the needle and attached suture through tissue during suturing. It is typically made of metal and has short serrated jaws at the distal end to provide better grip of the needle. It is available in a wide variety of sizes and designs, such as: 1) a self-retaining, scissors-like design with ring handles at the proximal end; 2) a tweezers-like design with bowed, hinged handles that are operated by squeezing them together; and 3) a heavy-duty pincer-like design. Some types may utilize inserts made of hard materials (e.g., carbide) and include scissor blades. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length4.75Inch

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
00840343727475Gen2G2G37279G2G372792026-04-22
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810055251544Surgical DesignSurgical Design, Inc.FHQ2026-06-06
00810055251551Surgical DesignSurgical Design, Inc.FHQ2026-06-06
00810212931654SURGIPROSSurgipros, LLCFHQ2026-06-01
00810055250721Surgical DesignSurgical Design, Inc.FHQ2026-05-29
00810055250738Surgical DesignSurgical Design, Inc.FHQ2026-05-29
00810055250745Surgical DesignSurgical Design, Inc.FHQ2026-05-29
00810055250752Surgical DesignSurgical Design, Inc.FHQ2026-05-29
00810055250783Surgical DesignSurgical Design, Inc.FHQ2026-05-29
00810055250790Surgical DesignSurgical Design, Inc.FHQ2026-05-29
00810055250806Surgical DesignSurgical Design, Inc.FHQ2026-05-29
00810055250813Surgical DesignSurgical Design, Inc.FHQ2026-05-29
00810055250820Surgical DesignSurgical Design, Inc.FHQ2026-05-29
00810055250844Surgical DesignSurgical Design, Inc.FHQ2026-05-29
00810055250851Surgical DesignSurgical Design, Inc.FHQ2026-05-29
00810055250882Surgical DesignSurgical Design, Inc.FHQ2026-05-29
00810055250905Surgical DesignSurgical Design, Inc.FHQ2026-05-29
00810055250912Surgical DesignSurgical Design, Inc.FHQ2026-05-29
00810189450028Surgical DesignSurgical Design, Inc.FHQ2026-05-29
00810189450035Surgical DesignSurgical Design, Inc.FHQ2026-05-29
00810189450066Surgical DesignSurgical Design, Inc.FHQ2026-05-29
00810189450073Surgical DesignSurgical Design, Inc.FHQ2026-05-29
00810189450080Surgical DesignSurgical Design, Inc.FHQ2026-05-29
00810189450103Surgical DesignSurgical Design, Inc.FHQ2026-05-29
G149TBSB7370TBS BASICSACME ENTERPRISE.FHQ2026-05-21
G149TBSB7380TBS BASICSACME ENTERPRISE.FHQ2026-05-21
G149TBSB7390TBS BASICSACME ENTERPRISE.FHQ2026-05-21
G149TBSB7400TBS BASICSACME ENTERPRISE.FHQ2026-05-21
08961104621824Mathieu Standard TipMELPEX BEAUTY INSTRUMENTSFHQ2026-05-21
08961104621831Mathieu Standard TipMELPEX BEAUTY INSTRUMENTSFHQ2026-05-21
08961104621848Mathieu Standard Tip TCMELPEX BEAUTY INSTRUMENTSFHQ2026-05-21