Dilapan-S

Primary DI
08595231700260
Brand
Dilapan-S
Company
MEDICEM Technology s.r.o.
Model
DS465
Catalog number
4x65 mm
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
2016-05-01
Public version status
Update
Distribution status
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
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
08595231700338PackageGS110Not in Commercial Distribution
08595231700345PackageGS125Not in Commercial Distribution
08595231703131PackageGS110In Commercial Distribution
08595231703148PackageGS125In Commercial Distribution
08595231700260PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08595231700338085952317003388595231700338
08595231700345085952317003458595231700345
08595231703131085952317031318595231703131
08595231703148085952317031488595231703148
08595231700260085952317002608595231700260

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
Special Storage Condition, Specify00Keep away from sun
Special Storage Condition, Specify00Keep in a dry place
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

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
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
08595231704657Dilapan-SDS4652014-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
08595231700291Dilapan-SMEDICEM Technology s.r.o.PKN2016-05-01