Dilapan-S

Primary DI
08595231700291
Brand
Dilapan-S
Company
MEDICEM Technology s.r.o.
Model
DS355
Catalog number
3x55 mm
Device description
Dilapan-S is a hygroscopic cervical dilator similar in shape to natural laminaria tents. It consists from the active part, made from the 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
2016-05-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PKNDilator, Cervical, Synthetic, Osmotic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PKNDilator, Cervical, Synthetic, OsmoticObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K143447000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K143447000Dilapan-SMedicem Technology S.R.O2015-04-17PKN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08595231700291PackageGS110In Commercial Distribution
08595231700307PackageGS125In Commercial Distribution
08595231703094PackageGS110In Commercial Distribution
08595231703100PackageGS125In Commercial Distribution
08595231700284PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08595231700291085952317002918595231700291
08595231700307085952317003078595231700307
08595231703094085952317030948595231703094
08595231703100085952317031008595231703100
08595231700284085952317002848595231700284

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
Length55Millimeter
Outer Diameter3Millimeter

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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
496847310
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
08595231703551Dilapan-SDS3552014-10-24
08595231704558Dilapan-SDS4552014-10-24
08595231704657Dilapan-SDS4652014-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08595231700260Dilapan-SMEDICEM Technology s.r.o.PKN2016-05-01
08595231700277Dilapan-SMEDICEM Technology s.r.o.PKN2016-05-01
08595231700284Dilapan-SMEDICEM Technology s.r.o.PKN2016-05-01
08595231700321Dilapan-SMEDICEM Technology s.r.o.PKN2016-05-01
08595231700345Dilapan-SMEDICEM Technology s.r.o.PKN2016-05-01