FDA.reportPublic FDA data

Gynex

Primary DI
GYNX3680230
Brand
Gynex
Company
GYNEX CORPORATION
Model
3680-23
Published
2023-12-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
GYNX3680230PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Gynaecological scissors, reusableA hand-held manual surgical instrument designed to cut tissues during a gynaecological surgical procedure; it is not intended for obstetric use. It is comprised of two pivoted shearing blades with finger and thumb ring-handles (i.e., not pinch-grip design) whereby the shearing action is directly adjacent to the handles (i.e., not alligator or endoscopic design). It is made of metal and available in a variety of blade designs; the blades may have carbide inserts along the cutting edges. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
012997685
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
GYNX32500Gynex32502023-12-13
GYNX32550Gynex32552023-12-13
GYNX80091Gynex80092023-12-19
GYNX80241Gynex80242023-12-19
GYNX80721Gynex80722023-12-19
GYNX81001Gynex81002023-12-19
GYNX81031Gynex81032023-12-19
GYNX82001Gynex82002023-12-19
GYNX292001Gynex29-2002023-12-26
GYNX293001Gynex29-3002023-12-26
GYNX298501Gynex29-8502023-12-26
GYNX31301Gynex31302023-12-26
GYNX31351Gynex31352023-12-26
GYNX32071Gynex32052023-12-26
GYNX16000Gynex16002023-12-26
GYNX291000Gynex29-1002023-12-26
GYNX292000Gynex29-3002023-12-26
GYNX293500Gynex29-3502023-12-26
GYNX295500Gynex29-5502023-12-26
GYNX297000Gynex29-7002023-12-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776395575MillenniumAvalign Technologies, Inc.LRW2026-07-14
00190776395582MillenniumAvalign Technologies, Inc.LRW2026-07-14
04059453162618Hermann Medizintechnik GmbHHermann Medizintechnik GmbHLRW2026-07-13
00850088713022PRINCETONPrinceton Medical Group, Inc.LRW2026-07-10
00850088713060PRINCETONPrinceton Medical Group, Inc.LRW2026-07-10
00850088713077PRINCETONPrinceton Medical Group, Inc.LRW2026-07-10
00850088713084PRINCETONPrinceton Medical Group, Inc.LRW2026-07-10
00850088713091PRINCETONPrinceton Medical Group, Inc.LRW2026-07-10
B382SD9032161000Surgical DirectSurgical Direct, Inc.LRW2026-07-10
B382SD90390213SC0Surgical DirectSurgical Direct, Inc.LRW2026-07-10
00850083275006Intrace USAPILOTIS TECH LLCLRW2026-07-03
00850083275013Intrace USAPILOTIS TECH LLCLRW2026-07-03
00850083275037Intrace USAPILOTIS TECH LLCLRW2026-07-03
00850083275044Intrace USAPILOTIS TECH LLCLRW2026-07-03
00850083275051Intrace USAPILOTIS TECH LLCLRW2026-07-03
00850083275068Intrace USAPILOTIS TECH LLCLRW2026-07-03
00850083275266Intrace USAPILOTIS TECH LLCLRW2026-07-03
00850083275273Intrace USAPILOTIS TECH LLCLRW2026-07-03
00850083275297Intrace USAPILOTIS TECH LLCLRW2026-07-03
00850083275303Intrace USAPILOTIS TECH LLCLRW2026-07-03
00850083275587Intrace USAPILOTIS TECH LLCLRW2026-07-03
00850083275716Intrace USAPILOTIS TECH LLCLRW2026-07-03
00850083275907Intrace USAPILOTIS TECH LLCLRW2026-07-03
00850083275914Intrace USAPILOTIS TECH LLCLRW2026-07-03
00850083275921Intrace USAPILOTIS TECH LLCLRW2026-07-03
00810055259342Surgical DesignSurgical Design, Inc.LRW2026-06-25
00810055259359Surgical DesignSurgical Design, Inc.LRW2026-06-25
00810055259366Surgical DesignSurgical Design, Inc.LRW2026-06-25
00810055259373Surgical DesignSurgical Design, Inc.LRW2026-06-25
00810158211254PRINCETONPrinceton Medical Group, Inc.LRW2026-06-23