FDA.report

Gynex

Primary DI
GYNX290200
Brand
Gynex
Company
GYNEX CORPORATION
Model
29020
Published
2023-12-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
HHFRemover, Intrauterine Device, Contraceptive, Hook-Type

Product Code Classifications

CodeDeviceSpecialtyClass
HHFRemover, Intrauterine Device, Contraceptive, Hook-TypeObstetrics/Gynecology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
GYNX290200PrimaryHIBCC0

GMDN Terms

TermDefinition
Intrauterine device removal hook, reusableA hand-held manual instrument intended to be used by a physician for the extraction of an intrauterine device (IUD). The proximal end forms a handle which may vary in shape and which tapers toward the distal end to form a hook. It is typically made of high-grade stainless steel. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
012997685
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 DIBrandModelCatalogPublished
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
GYNX298500Gynex29-8502023-12-26
GYNX299000Gynex29-9002023-12-26
GYNX31300Gynex31302023-12-26
GYNX31350Gynex31352023-12-26
GYNX32050Gynex32052023-12-26
GYNX32070Gynex32052023-12-26
GYNXNHL34500GynexNHL34502023-12-26
GYNXNHMH3410140GynexNHMH3410-142023-12-26
GYNXNHMH3410160GynexNHMH3410-162023-12-26
GYNXNHMH3410180GynexNHMH3410-182023-12-26
GYNXNHMH3410200GynexNHMH3410-202023-12-26
GYNXNHW34000GynexNHW34002023-12-26
GYNXS0010GynexS0012023-12-26

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
05010058178489InstrapacROBINSON HEALTHCARE LIMITEDHHF2025-05-21
00194613032456MSI Precision Specialty InstrumentsMed Saver, Inc.HHF2025-03-21
00887482040751Symmetry SurgicalSYMMETRY SURGICAL INC.HHF2024-09-05
00840183500092BR Surgical, LLCBR Surgical, LLCHHF2024-02-29
00840183500870BR Surgical, LLCBR Surgical, LLCHHF2024-02-29
00840183502263BR Surgical, LLCBR Surgical, LLCHHF2024-02-29
GYNX291000GynexGYNEX CORPORATIONHHF2023-12-26
GYNX292000GynexGYNEX CORPORATIONHHF2023-12-26
GYNX293500GynexGYNEX CORPORATIONHHF2023-12-26
GYNX295500GynexGYNEX CORPORATIONHHF2023-12-26
GYNX298000GynexGYNEX CORPORATIONHHF2023-12-26
GYNX298500GynexGYNEX CORPORATIONHHF2023-12-26
GYNX299000GynexGYNEX CORPORATIONHHF2023-12-26
G586OB96417600Novo SurgicalNOVO SURGICAL, INC.HHF2023-12-18
G586OB96417670Novo SurgicalNOVO SURGICAL, INC.HHF2023-12-18
G586OB96417680Novo SurgicalNOVO SURGICAL, INC.HHF2023-12-18
GYNX290100GynexGYNEX CORPORATIONHHF2023-12-13
05010058170247InstrapacROBINSON HEALTHCARE LIMITEDHHF2023-08-08
00190776250737AvalignAVALIGN TECHNOLOGIES, INC.HHF2023-06-23
00842962162101HNM MEDICALHNM STAINLESS, LLC.HHF2023-05-27
00842962162118HNM MEDICALHNM STAINLESS, LLC.HHF2023-05-27
00842962129036HNM MEDICALHNM STAINLESS, LLC.HHF2023-03-30
00842962129043HNM MEDICALHNM STAINLESS, LLC.HHF2023-03-30
54026704792172PILLINGTELEFLEX INCORPORATEDHHF2022-12-08
00842331164248Novo Surgical Inc. NOVO SURGICAL, INC.HHF2022-11-13
00842331152047Novo Surgical Inc. NOVO SURGICAL, INC.HHF2022-11-12
00842331146190Novo Surgical Inc. NOVO SURGICAL, INC.HHF2022-11-11
00840306806780Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.HHF2022-11-08
00840306806797Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.HHF2022-11-07
00888937019667Double IUD ExtractorCoopersurgical, Inc.HHF2022-10-30