DEVICE: Dilapan-S (08595231700260)

Device Identifier (DI) Information

Dilapan-S
DS465
In Commercial Distribution
4x65 mm
MEDICEM Technology s.r.o.
08595231700260
GS1

1
496847310 *Terms of Use
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.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
34965 Hygroscopic cervical dilator
A 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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
PKN Dilator, Cervical, Synthetic, Osmotic
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K143447 000
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Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Special Storage Condition, Specify: Keep away from sun
Special Storage Condition, Specify: Keep in a dry place
Storage Environment Temperature: between 15 and 30 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
Outer Diameter: 4 Millimeter
Length: 65 Millimeter
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Device Record Status

1c21b876-1bac-42af-8702-b6c57fc50a32
February 27, 2023
5
May 01, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
08595231700345 25 08595231700260 2023-02-27 Not in Commercial Distribution box
08595231700338 10 08595231700260 2023-02-27 Not in Commercial Distribution box
08595231703131 10 08595231700260 In Commercial Distribution box
08595231703148 25 08595231700260 In Commercial Distribution box
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
540-3759380
bob@hpsrx.com
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