FDA.reportPublic FDA data

GEN2

Primary DI
00840343715427
Brand
GEN2
Company
SURGIX MEDICAL LLC
Model
G2G35885
Catalog number
G2G35885
Device description
HEPARIN NEEDLES, 3.7MM TIP, 5.5CM LONG
Published
2022-12-29
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
KBRNeedle, Tonsil Suturing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KBRNeedle, Tonsil SuturingEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840343715427PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840343715427008403437154278403437154270840343715427

GMDN Terms#

Term, Definition table
TermDefinition
Exploratory blunt needle, reusableA slender hand-held manual instrument designed with a dull curved tip intended to prevent damage to sensitive and delicate tissues while it is being used to explore within the body. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length5.5Centimeter

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
00194613021894MSI Precision Specialty InstrumentsMed Saver, Inc.KBR2025-08-01
00194613046040MSI Precision Specialty InstrumentsMed Saver, Inc.KBR2025-08-01
00194613112448MSI Precision Specialty InstrumentsMed Saver, Inc.KBR2025-08-01
00194613115449MSI Precision Specialty InstrumentsMed Saver, Inc.KBR2025-08-01
00194613109752MSI Precision Specialty InstrumentsMed Saver, Inc.KBR2025-03-21
00190776388744MillenniumAvalign Technologies, Inc.KBR2024-11-14
00887482173800Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.KBR2024-08-15
00887482046562Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.KBR2024-08-01
00887482119167Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.KBR2024-08-01
00887482119174Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.KBR2024-08-01
00887482123966Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.KBR2024-08-01
00887482123973Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.KBR2024-08-01
00840343722203GEN2SURGIX MEDICAL LLCKBR2024-04-23
G586E8306200Novo SurgicalNOVO SURGICAL, INC.KBR2023-12-18
00840343720414GEN2SURGIX MEDICAL LLCKBR2023-12-08
00190776303990MillenniumAvalign Technologies, Inc.KBR2023-11-16
00190776304904MillenniumAvalign Technologies, Inc.KBR2023-11-16
00190776044077AvalignAvalign Technologies, Inc.KBR2023-09-28
00190776290733MILLENNIUMAvalign Technologies, Inc.KBR2023-09-28
00190776319625MILLENNIUMAvalign Technologies, Inc.KBR2023-09-28
00190776319700MILLENNIUMAvalign Technologies, Inc.KBR2023-09-28
00190776319885MILLENNIUMAvalign Technologies, Inc.KBR2023-09-28
00190776322281MILLENNIUMAvalign Technologies, Inc.KBR2023-09-28
00190776322298MILLENNIUMAvalign Technologies, Inc.KBR2023-09-28
00190776373801MILLENNIUMAvalign Technologies, Inc.KBR2023-09-28
00190776378264MILLENNIUMAvalign Technologies, Inc.KBR2023-09-28
00840343716240GEN2SURGIX MEDICAL LLCKBR2023-03-22
14026704804815PILLINGTELEFLEX INCORPORATEDKBR2022-12-08
14026704805010PILLINGTELEFLEX INCORPORATEDKBR2022-12-08
14026704805027PILLINGTELEFLEX INCORPORATEDKBR2022-12-08