FDA.reportPublic FDA data

MedGyn Laminaria

Primary DI
M803021006
Brand
MedGyn Laminaria
Company
MEDGYN PRODUCTS, INC.
Model
size 6
Catalog number
021006
Device description
Dilator of uterine cervix
Published
2016-08-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
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
M803021006PrimaryHIBCC0

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.

Regulatory Flags#

DUNS number
103913430
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M8030030134Baby Tischler Biopsy Punch Titanium"Baby Tischler Biopsy Punch Titanium 10"" (254mm) 0301342025-11-16
M8030030139Tischler Biopsy Punch Titanium"Tischler Biopsy Punch Titanium 8 1/2"" (216mm) - 0301392025-11-16
M803029801Tischler Biopsy Punch "Tischler Biopsy Punch 10"" (254mm) Up"0298012025-11-16
M803029802Tischler Biopsy Punch "Tischler Biopsy Punch 10"" (254mm) Down"0298022025-11-16
M803029803Tischler Biopsy Punch"Tischler Biopsy Punch 10"" (254mm) Left"0298032025-11-16
M803029804Tischler Biopsy Punch "Tischler Biopsy Punch 10"" (254mm) Right"0298042025-11-16
M803029811Baby Tischler Biopsy Punch "Baby Tischler Biopsy Punch 10"" (254mm) Up "0298112025-11-16
M803029812Baby Tischler Biopsy Punch "Baby Tischler Biopsy Punch 10"" (254mm) Down"0298122025-11-16
M803029813Baby Tischler Biopsy Punch"Baby Tischler Biopsy Punch 10"" (254mm) Left"0298132025-11-16
M803029814Baby Tischler Biopsy Punch "Baby Tischler Biopsy Punch 10"" (254mm) Right"0298142025-11-16
M803030101Tischler Biopsy Punch"Tischler Biopsy Punch 81/2"" (216mm)"0301012025-11-16
M80303010110"Tischler Biopsy Punch 10"" (254mm)""Tischler Biopsy Punch 10"" (254mm)"030101102025-11-16
M803030102Baby Tischler Biopsy Punch"Baby Tischler Biopsy Punch 81/2"" (216mm)"0301022025-11-16
M80303010210Baby Tischler Biopsy Punch"Baby Tischler Biopsy Punch 10""(254mm)"030102102025-11-16
M803030103Kevorkian Biopsy Punch"Kevorkian Biopsy Punch 81/2"" (216mm)"0301032025-11-16
M80303010310Kevorkian Biopsy Punch"Kevorkian Biopsy Punch 10"" (254mm)"030103102025-11-16
M803030104Rotating Tischler Biopsy PunchRotating Tischler Biopsy Punch0301042025-11-16
M803030105Rotating Baby Tischler Biopsy PunchRotating Baby Tischler Biopsy Punch0301052025-11-16
M803030106Rotating Kevorkian Biopsy PunchRotating Kevorkian Biopsy Punch0301062025-11-16
M803030107Rotating Burke Biopsy PunchRotating Burke Biopsy Punch0301072025-11-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06974213565783MalibuWENZHOU TIDE-OPTICAL CO.,LTDHDY2026-04-13
GYNX161031LaminariaGYNEX CORPORATIONHDY2017-01-19
GYNX161041LaminariaGYNEX 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
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