FDA.reportPublic FDA data

GEN2

Primary DI
00840343711351
Brand
GEN2
Company
SURGIX MEDICAL LLC
Model
G2N72512
Catalog number
G2N72512
Device description
"CUSHING IVD 2X10MM 5"" STR"
Published
2022-10-25
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
HAERongeur, Manual

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HAERongeur, ManualNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G277G2N725120PreviousHIBCC0
00840343711351PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840343711351008403437113518403437113510840343711351

GMDN Terms#

Term, Definition table
TermDefinition
Spinal rongeurA hand-held manual surgical instrument with sharp, scoop-shaped jaws designed for cutting tough tissues (intervertebral disk) or bone, through a cutting/biting action, during open spinal surgery (e.g., laminectomy, discectomy). It is typically made of metal and designed to withstand the forces required to bite over tough tissue. It is not intended for endoscopic access. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Length5Inch

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
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
00810220800089Adler Instrument CompanyAdler, Inc.HAE2026-05-26
04057034294543Punch, acc. Kerrison, K-Rex™ 40° upwards 18cm 1mm,w.ejectorGeister Medizintechnik GmbHHAE2026-05-26
04058749092523NAFehling Instruments GmbH & Co. KGHAE2026-03-05
00190776416515MillenniumAvalign Technologies, Inc.HAE2026-02-16
00887482023389SymmetryASPEN SURGICAL PRODUCTS, INC.HAE2026-02-15
00887482023396SymmetryASPEN SURGICAL PRODUCTS, INC.HAE2026-02-15
00887482023402SymmetryASPEN SURGICAL PRODUCTS, INC.HAE2026-02-15
00887482156186SymmetryASPEN SURGICAL PRODUCTS, INC.HAE2026-02-15
00887482156223SymmetryASPEN SURGICAL PRODUCTS, INC.HAE2026-02-15
20887482023376SymmetryASPEN SURGICAL PRODUCTS, INC.HAE2026-02-15
04058749089776NAFehling Instruments GmbH & Co. KGHAE2025-09-01
04046955741212AESCULAPAESCULAP, INC.HAE2025-08-17
04046955741229AESCULAPAESCULAP, INC.HAE2025-08-17
04046955741236AESCULAPAESCULAP, INC.HAE2025-08-17
04046955741243AESCULAPAESCULAP, INC.HAE2025-08-17
04046955741250AESCULAPAESCULAP, INC.HAE2025-08-17
04046955741267AESCULAPAESCULAP, INC.HAE2025-08-17
04046955741274AESCULAPAESCULAP, INC.HAE2025-08-17
04046955741281AESCULAPAESCULAP, INC.HAE2025-08-17
04046955741298AESCULAPAESCULAP, INC.HAE2025-08-17
04046955741304AESCULAPAESCULAP, INC.HAE2025-08-17
04046955741311AESCULAPAESCULAP, INC.HAE2025-08-17
04046955741328AESCULAPAESCULAP, INC.HAE2025-08-17
04046955741335AESCULAPAESCULAP, INC.HAE2025-08-17
04046955741342AESCULAPAESCULAP, INC.HAE2025-08-17
04046955741359AESCULAPAESCULAP, INC.HAE2025-08-17
04046955741366AESCULAPAESCULAP, INC.HAE2025-08-17
04046955741373AESCULAPAESCULAP, INC.HAE2025-08-17
04046955741380AESCULAPAESCULAP, INC.HAE2025-08-17
04046955741397AESCULAPAESCULAP, INC.HAE2025-08-17