Dilapan-S

Primary DI
08595231704657
Brand
Dilapan-S
Company
MEDICEM Technology s.r.o.
Model
DS465
Device description
Dilapan-S is a hygroscopic cervical dilator similar in shape to natural laminaria tents. It consists from the active part, made fromthe hydrophilic material (AQUACRYL 90), from the polypropylene handle, attached to the active part by the isocyanate adhesive,and from the polyamide signal string. Dilapan-S is capable of increasing in diameter as it absorbs moisture from the genital tract.
Published
2014-10-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LOBDilator, Cervical, Synthetic Osmotic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LOBDilator, Cervical, Synthetic, Osmotic, Pregnancy TerminationUnknown3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08595231700055PackageGS110Not in Commercial Distribution
08595231700062PackageGS125Not in Commercial Distribution
08595231704657PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08595231700055085952317000558595231700055
08595231700062085952317000628595231700062
08595231704657085952317046578595231704657

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length65Millimeter
Outer Diameter4Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature15 Degrees Celsius30 Degrees Celsius
Special Storage Condition, Specify00Keep away from sun
Special Storage Condition, Specify00Keep in a dry place

Contacts#

Phone, Email table
PhoneEmail
540-3759380bob@hpsrx.com

Regulatory Flags#

DUNS number
496847310
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08595231700260Dilapan-SDS4654x65 mm2016-05-01
08595231700277Dilapan-SDS4554x55 mm2016-05-01
08595231700321Dilapan-SDS4554x55 mm2016-05-01
08595231700284Dilapan-SDS3553x55 mm2016-05-01
08595231700345Dilapan-SDS4654x65 mm2016-05-01
08595231700291Dilapan-SDS3553x55 mm2016-05-01
08595231703551Dilapan-SDS3552014-10-24
08595231704558Dilapan-SDS4552014-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08595231703551Dilapan-SMEDICEM Technology s.r.o.LOB2014-10-24
08595231704558Dilapan-SMEDICEM Technology s.r.o.LOB2014-10-24