FDA.reportPublic FDA data

Gynex

Primary DI
GYNX32071
Brand
Gynex
Company
GYNEX CORPORATION
Model
3205
Published
2023-12-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
GYNX32071PrimaryHIBCC0
GYNX32070Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dressing/utility forceps, scissors-like, single-useA hand-held manual instrument designed primarily for non-dedicated grasping of devices, sponges and/or dressings during a procedure; it is not intended for endoscopic use. It has a scissors-like hinged design with ring handles and blades (non-cutting) that may be available in a range of sizes or designs. It may be intended for use at a specific anatomy. This is a single-use device.

Regulatory Flags#

DUNS number
012997685
Device count
12
Premarket exempt
true
Lot or batch
true
No natural rubber latex
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
GYNX16000Gynex16002023-12-26
GYNX291000Gynex29-1002023-12-26
GYNX292000Gynex29-3002023-12-26
GYNX293500Gynex29-3502023-12-26
GYNX295500Gynex29-5502023-12-26
GYNX297000Gynex29-7002023-12-26
GYNX298000Gynex29-8002023-12-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776435448MillenniumAvalign Technologies, Inc.GEN2026-10-19
00840329838669N/ABLACK & BLACK SURGICAL, INC.GEN2026-10-15
00190776435011MillenniumAvalign Technologies, Inc.GEN2026-10-14
00190776435035MillenniumAvalign Technologies, Inc.GEN2026-10-14
00190776434816MillenniumAvalign Technologies, Inc.GEN2026-10-13
00190776434779MillenniumAvalign Technologies, Inc.GEN2026-10-12
04058749012842NAFehling Instruments GmbH & Co. KGGEN2026-10-12
00190776434175MillenniumAvalign Technologies, Inc.GEN2026-10-09
00198506095801ELMED INCORPORATEDELMED INCORPORATEDGEN2026-10-09
00198506095818ELMED INCORPORATEDELMED INCORPORATEDGEN2026-10-09
00198506095825ELMED INCORPORATEDELMED INCORPORATEDGEN2026-10-09
00198506095832ELMED INCORPORATEDELMED INCORPORATEDGEN2026-10-09
00840314252449gSourceGSOURCE LLCGEN2026-10-09
00190776436605MilleniumAvalign Technologies, Inc.GEN2026-10-08
00190776433604MillenniumAvalign Technologies, Inc.GEN2026-10-07
00190776434380MillenniumAvalign Technologies, Inc.GEN2026-10-07
B382SD6713210Surgical DirectSurgical Direct, Inc.GEN2026-10-07
B382SD6713290Surgical DirectSurgical Direct, Inc.GEN2026-10-07
B382SD6520450Surgical DirectSurgical Direct, Inc.GEN2026-10-06
B382SD6562120Surgical DirectSurgical Direct, Inc.GEN2026-10-06
00190776433048MillenniumAvalign Technologies, Inc.GEN2026-10-01
00190776433130MillenniumAvalign Technologies, Inc.GEN2026-10-01
00190776433147MillenniumAvalign Technologies, Inc.GEN2026-10-01
00190776433178MillenniumAvalign Technologies, Inc.GEN2026-10-01
B382SD8160490Surgical DirectSurgical Direct, Inc.GEN2026-09-30
00190776432829MillenniumAvalign Technologies, Inc.GEN2026-09-29
00190776432898MillenniumAvalign Technologies, Inc.GEN2026-09-29
B382SD4937851340Surgical DirectSurgical Direct, Inc.GEN2026-09-29
00190776432522MillenniumAvalign Technologies, Inc.GEN2026-09-28
00190776432553MillenniumAvalign Technologies, Inc.GEN2026-09-28