FDA.reportPublic FDA data

Laminaria

Primary DI
GYNX161041
Brand
Laminaria
Company
GYNEX CORPORATION
Model
16-104
Published
2017-01-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
HDYDilator, Cervical, Hygroscopic-Laminaria

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HDYDilator, Cervical, Hygroscopic-LaminariaObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
GYNX161041PrimaryHIBCC0
GYNX161040Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Hygroscopic cervical dilatorA sterile plug of expansible material intended to dilate the uterine cervix by gradually swelling to several times its original diameter through the absorption of moisture from the cervix over a period of several hours (typically <24 hours). It is made of synthetic polymer and/or plant-derived materials and typically has features (e.g., attached cord, handle) intended to assist anchoring, locating, and easy removal. The device is typically used to dilate the cervical canal for uterine curettage, labour induction, midterm abortions, intrauterine device (IUD) placement and removal, and radium placement. This is a single-use device.

Sterilization Methods#

Method table
Method

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
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
06974213565783MalibuWENZHOU TIDE-OPTICAL CO.,LTDHDY2026-04-13
GYNX161031LaminariaGYNEX CORPORATIONHDY2017-01-19
GYNX161051LaminariaGYNEX CORPORATIONHDY2017-01-19
00888937003307DilateriaCoopersurgical, Inc.HDY2016-09-20
00888937003314DilateriaCoopersurgical, Inc.HDY2016-09-20
00888937003321DilateriaCoopersurgical, Inc.HDY2016-09-20
00888937003338DilateriaCoopersurgical, Inc.HDY2016-09-20
60888937003309DilateriaCoopersurgical, Inc.HDY2016-09-20
60888937003316DilateriaCoopersurgical, Inc.HDY2016-09-20
60888937003323DilateriaCoopersurgical, Inc.HDY2016-09-20
60888937003330DilateriaCoopersurgical, Inc.HDY2016-09-20
M803021002MedGyn LaminariaMEDGYN PRODUCTS, INC.HDY2016-08-29
M803021003MedGyn LaminariaMEDGYN PRODUCTS, INC.HDY2016-08-29
M803021004MedGyn LaminariaMEDGYN PRODUCTS, INC.HDY2016-08-29
M803021005MedGyn LaminariaMEDGYN PRODUCTS, INC.HDY2016-08-29
M803021006MedGyn LaminariaMEDGYN PRODUCTS, INC.HDY2016-08-29
M803021008MedGyn LaminariaMEDGYN PRODUCTS, INC.HDY2016-08-29
M803021010MedGyn LaminariaMEDGYN PRODUCTS, INC.HDY2016-08-29
M803021014MedGyn LaminariaMEDGYN PRODUCTS, INC.HDY2016-08-29
M803021015MedGyn LaminariaMEDGYN PRODUCTS, INC.HDY2016-08-29
M803021016MedGyn LaminariaMEDGYN PRODUCTS, INC.HDY2016-08-29
M803021018MedGyn LaminariaMEDGYN PRODUCTS, INC.HDY2016-08-29
M803021022MedGyn LaminariaMEDGYN PRODUCTS, INC.HDY2016-08-29
M803021023MedGyn LaminariaMEDGYN PRODUCTS, INC.HDY2016-08-29
M803021024MedGyn LaminariaMEDGYN PRODUCTS, INC.HDY2016-08-29
M803021025MedGyn LaminariaMEDGYN PRODUCTS, INC.HDY2016-08-29
M803021026MedGyn LaminariaMEDGYN PRODUCTS, INC.HDY2016-08-29