AccessGUDID - DEVICE: Dilapan-S (08595231700260)

GUDID

Device Identifier (DI) Information

Brand Name: Dilapan-S
Version or Model: DS465
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 4x65 mm
Company Name: MEDICEM Technology s.r.o.

Primary DI Number: 08595231700260
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 496847310 *Terms of Use

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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

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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

FDA Product Code

[?]

Product Code	Product Code Name
PKN	Dilator, Cervical, Synthetic, Osmotic

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

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

Clinically Relevant Size

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Size Type Text
Outer Diameter: 4 Millimeter
Length: 65 Millimeter

Device Record Status

Public Device Record Key: 1c21b876-1bac-42af-8702-b6c57fc50a32
Public Version Date: February 27, 2023
Public Version Number: 5
DI Record Publish Date: May 01, 2016

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