Dilapan-S 4x65 mm

GUDID 08595231700345

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 ID08595231700345
NIH Device Record Key1c21b876-1bac-42af-8702-b6c57fc50a32
Commercial Distribution StatusIn Commercial Distribution
Brand NameDilapan-S
Version Model NumberDS465
Catalog Number4x65 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
Email[email protected]

Device Dimensions

Length65 Millimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS108595231700260 [Primary]
GS108595231700338 [Package]
Contains: 08595231700260
Package: box [10 Units]
Discontinued: 2023-02-27
In Commercial Distribution
GS108595231700345 [Package]
Contains: 08595231700260
Package: box [25 Units]
Discontinued: 2023-02-27
In Commercial Distribution
GS108595231703131 [Package]
Contains: 08595231700260
Package: box [10 Units]
In Commercial Distribution
GS108595231703148 [Package]
Contains: 08595231700260
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 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.
08595231700345Dilapan-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.

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