FDA.reportPublic FDA data

Gen2

Primary DI
00840343718749
Brand
Gen2
Company
SURGIX MEDICAL LLC
Model
G2G37075
Catalog number
G2G37075
Device description
BONE HOOK, T-HANDLE, SHARP, HOOK 21MM DEPTH, 7"
Published
2023-10-31
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
GENForceps, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GENForceps, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840343718749PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840343718749008403437187498403437187490840343718749

GMDN Terms#

Term, Definition table
TermDefinition
Bone hookA hand-held, surgical instrument used for hooking around or into bone, typically to grasp, hold, and apply traction to the bone during a surgical intervention. It is a shaft-like instrument with a robust design and can have a singular hook or multiple hooks at the distal end and a handle of various designs at the proximal end. It is made of high-grade stainless steel. It is sometimes called a bone retractor. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length7Inch

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
00198506091124ELMED INCORPORATEDELMED INCORPORATEDGEN2026-05-26
00846159039269SCANLAN® ForcepsSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039276SCANLAN® ForcepsSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039283SCANLAN® ForcepsSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039290SCANLAN® ForcepsSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039306SCANLAN® ClampSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039313SCANLAN® ClampSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039320SCANLAN® ForcepsSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039337SCANLAN® ForcepsSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039344SCANLAN® ForcepsSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039351SCANLAN® ClampSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039368SCANLAN® ClampSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039375SCANLAN® ClampSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039382SCANLAN® ClampSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039399SCANLAN® ForcepsSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039405SCANLAN® ForcepsSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039412SCANLAN® ClampSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039429SCANLAN® ClampSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039436SCANLAN® ClampSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039443SCANLAN® ForcepsSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039450SCANLAN® ClampSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039467SCANLAN® ClampSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039474SCANLAN® ClampSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039481SCANLAN® ClampSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039498SCANLAN® ForcepsSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039504SCANLAN® ForcepsSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039511SCANLAN® ClampSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039528SCANLAN® ClampSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039535SCANLAN® ClampSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039542SCANLAN® ForcepsSCANLAN INTERNATIONAL INCGEN2026-05-26