Dilapan-S 3x55 mm

GUDID 08595231700291

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.

MEDICEM Technology s.r.o.

Hygroscopic cervical dilator
Primary Device ID08595231700291
NIH Device Record Key86c59eb4-0fcf-4d24-ae2a-5a298e36ff84
Commercial Distribution StatusIn Commercial Distribution
Brand NameDilapan-S
Version Model NumberDS355
Catalog Number3x55 mm
Company DUNS496847310
Company NameMEDICEM Technology s.r.o.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone540-3759380
Emailbob@hpsrx.com
Phone540-3759380
Emailbob@hpsrx.com
Phone540-3759380
Emailbob@hpsrx.com
Phone540-3759380
Emailbob@hpsrx.com
Phone540-3759380
Emailbob@hpsrx.com
Phone540-3759380
Emailbob@hpsrx.com
Phone540-3759380
Emailbob@hpsrx.com
Phone540-3759380
Emailbob@hpsrx.com
Phone540-3759380
Emailbob@hpsrx.com
Phone540-3759380
Emailbob@hpsrx.com
Phone540-3759380
Emailbob@hpsrx.com
Phone540-3759380
Emailbob@hpsrx.com
Phone540-3759380
Emailbob@hpsrx.com
Phone540-3759380
Emailbob@hpsrx.com
Phone540-3759380
Emailbob@hpsrx.com
Phone540-3759380
Emailbob@hpsrx.com
Phone540-3759380
Emailbob@hpsrx.com
Phone540-3759380
Emailbob@hpsrx.com

Device Dimensions

Length55 Millimeter
Outer Diameter3 Millimeter
Length55 Millimeter
Outer Diameter3 Millimeter
Length55 Millimeter
Outer Diameter3 Millimeter
Length55 Millimeter
Outer Diameter3 Millimeter
Length55 Millimeter
Outer Diameter3 Millimeter
Length55 Millimeter
Outer Diameter3 Millimeter
Length55 Millimeter
Outer Diameter3 Millimeter
Length55 Millimeter
Outer Diameter3 Millimeter
Length55 Millimeter
Outer Diameter3 Millimeter
Length55 Millimeter
Outer Diameter3 Millimeter
Length55 Millimeter
Outer Diameter3 Millimeter
Length55 Millimeter
Outer Diameter3 Millimeter
Length55 Millimeter
Outer Diameter3 Millimeter
Length55 Millimeter
Outer Diameter3 Millimeter
Length55 Millimeter
Outer Diameter3 Millimeter
Length55 Millimeter
Outer Diameter3 Millimeter
Length55 Millimeter
Outer Diameter3 Millimeter
Length55 Millimeter

Operating and Storage Conditions

Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sun
Special Storage Condition, SpecifyBetween 0 and 0 *Keep in a dry place
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sun
Special Storage Condition, SpecifyBetween 0 and 0 *Keep in a dry place
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sun
Special Storage Condition, SpecifyBetween 0 and 0 *Keep in a dry place
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sun
Special Storage Condition, SpecifyBetween 0 and 0 *Keep in a dry place
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sun
Special Storage Condition, SpecifyBetween 0 and 0 *Keep in a dry place
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sun
Special Storage Condition, SpecifyBetween 0 and 0 *Keep in a dry place
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sun
Special Storage Condition, SpecifyBetween 0 and 0 *Keep in a dry place
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sun
Special Storage Condition, SpecifyBetween 0 and 0 *Keep in a dry place
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sun
Special Storage Condition, SpecifyBetween 0 and 0 *Keep in a dry place
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sun
Special Storage Condition, SpecifyBetween 0 and 0 *Keep in a dry place
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sun
Special Storage Condition, SpecifyBetween 0 and 0 *Keep in a dry place
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sun
Special Storage Condition, SpecifyBetween 0 and 0 *Keep in a dry place
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sun
Special Storage Condition, SpecifyBetween 0 and 0 *Keep in a dry place
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sun
Special Storage Condition, SpecifyBetween 0 and 0 *Keep in a dry place
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sun
Special Storage Condition, SpecifyBetween 0 and 0 *Keep in a dry place
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sun
Special Storage Condition, SpecifyBetween 0 and 0 *Keep in a dry place
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sun
Special Storage Condition, SpecifyBetween 0 and 0 *Keep in a dry place
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS108595231700284 [Primary]
GS108595231700291 [Package]
Contains: 08595231700284
Package: box [10 Units]
Discontinued: 2023-02-20
In Commercial Distribution
GS108595231700307 [Package]
Contains: 08595231700284
Package: box [25 Units]
Discontinued: 2023-02-20
In Commercial Distribution
GS108595231703094 [Package]
Contains: 08595231700284
Package: box [10 Units]
In Commercial Distribution
GS108595231703100 [Package]
Contains: 08595231700284
Package: box [25 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PKNDilator, Cervical, Synthetic, Osmotic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-03-25
Device Publish Date2016-05-01

On-Brand Devices [Dilapan-S]

08595231700291Dilapan-S is a hygroscopic cervical dilator similar in shape to natural laminaria tents. It cons
08595231700345Dilapan-S is a hygroscopic cervical dilator similar in shape to natural laminaria tents. It cons
08595231700321Dilapan-S is a hygroscopic cervical dilator similar in shape to natural laminaria tents. It cons

Trademark Results [Dilapan-S]

Mark Image

Registration | Serial
Company
Trademark
Application Date
DILAPAN-S
DILAPAN-S
79183084 5080094 Live/Registered
MEDICEM Technology s.r.o.
2015-12-22
DILAPAN-S
DILAPAN-S
76173875 2729892 Dead/Cancelled
MEDICEM INTERNATIONAL GMBH
2000-12-01

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