Dilapan-S 4x55 mm
GUDID 08595231700321
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 ID | 08595231700321 |
| NIH Device Record Key | f097a97d-be02-4320-b968-47cdd18ff365 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Dilapan-S |
| Version Model Number | DS455 |
| Catalog Number | 4x55 mm |
| Company DUNS | 496847310 |
| Company Name | MEDICEM Technology s.r.o. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 540-3759380 |
| bob@hpsrx.com | |
| Phone | 540-3759380 |
| bob@hpsrx.com | |
| Phone | 540-3759380 |
| bob@hpsrx.com | |
| Phone | 540-3759380 |
| bob@hpsrx.com | |
| Phone | 540-3759380 |
| bob@hpsrx.com | |
| Phone | 540-3759380 |
| bob@hpsrx.com | |
| Phone | 540-3759380 |
| bob@hpsrx.com | |
| Phone | 540-3759380 |
| bob@hpsrx.com | |
| Phone | 540-3759380 |
| bob@hpsrx.com | |
| Phone | 540-3759380 |
| bob@hpsrx.com | |
| Phone | 540-3759380 |
| bob@hpsrx.com | |
| Phone | 540-3759380 |
| bob@hpsrx.com | |
| Phone | 540-3759380 |
| bob@hpsrx.com | |
| Phone | 540-3759380 |
| bob@hpsrx.com | |
| Phone | 540-3759380 |
| bob@hpsrx.com | |
| Phone | 540-3759380 |
| bob@hpsrx.com | |
| Phone | 540-3759380 |
| bob@hpsrx.com |
Device Dimensions
| Outer Diameter | 4 Millimeter |
| Length | 55 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 55 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 55 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 55 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 55 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 55 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 55 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 55 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 55 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 55 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 55 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 55 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 55 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 55 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 55 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 55 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 55 Millimeter |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sun |
| Special Storage Condition, Specify | Between 0 and 0 *Keep in a dry place |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sun |
| Special Storage Condition, Specify | Between 0 and 0 *Keep in a dry place |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sun |
| Special Storage Condition, Specify | Between 0 and 0 *Keep in a dry place |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sun |
| Special Storage Condition, Specify | Between 0 and 0 *Keep in a dry place |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sun |
| Special Storage Condition, Specify | Between 0 and 0 *Keep in a dry place |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sun |
| Special Storage Condition, Specify | Between 0 and 0 *Keep in a dry place |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sun |
| Special Storage Condition, Specify | Between 0 and 0 *Keep in a dry place |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sun |
| Special Storage Condition, Specify | Between 0 and 0 *Keep in a dry place |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sun |
| Special Storage Condition, Specify | Between 0 and 0 *Keep in a dry place |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sun |
| Special Storage Condition, Specify | Between 0 and 0 *Keep in a dry place |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sun |
| Special Storage Condition, Specify | Between 0 and 0 *Keep in a dry place |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sun |
| Special Storage Condition, Specify | Between 0 and 0 *Keep in a dry place |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sun |
| Special Storage Condition, Specify | Between 0 and 0 *Keep in a dry place |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sun |
| Special Storage Condition, Specify | Between 0 and 0 *Keep in a dry place |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sun |
| Special Storage Condition, Specify | Between 0 and 0 *Keep in a dry place |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sun |
| Special Storage Condition, Specify | Between 0 and 0 *Keep in a dry place |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sun |
| Special Storage Condition, Specify | Between 0 and 0 *Keep in a dry place |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08595231700277 [Primary] |
| GS1 | 08595231700314 [Package] Contains: 08595231700277 Package: box [10 Units] Discontinued: 2023-02-27 Not in Commercial Distribution |
| GS1 | 08595231700321 [Package] Contains: 08595231700277 Package: box [25 Units] Discontinued: 2023-02-27 Not in Commercial Distribution |
| GS1 | 08595231703117 [Package] Contains: 08595231700277 Package: box [10 Units] In Commercial Distribution |
| GS1 | 08595231703124 [Package] Contains: 08595231700277 Package: box [25 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K143447
FDA Product Code
| PKN | Dilator, Cervical, Synthetic, Osmotic |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2023-02-27 |
| Device Publish Date | 2016-05-01 |
On-Brand Devices [Dilapan-S]
| 08595231700291 | Dilapan-S is a hygroscopic cervical dilator similar in shape to natural laminaria tents. It cons |
| 08595231700345 | Dilapan-S is a hygroscopic cervical dilator similar in shape to natural laminaria tents. It cons |
| 08595231700321 | Dilapan-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 79183084 5080094 Live/Registered |
MEDICEM Technology s.r.o. 2015-12-22 |
 DILAPAN-S 76173875 2729892 Dead/Cancelled |
MEDICEM INTERNATIONAL GMBH 2000-12-01 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.