FDA UDI
In Commercial Distribution
🇺🇸 United States
Dilapan-S
DI: 08595231700284
·
Model: DS355
·
MEDICEM Technology s.r.o.
Product Codes
1
GMDN Terms
1
Identifiers
5
Pkg Device Count
1
Basic Information
- Brand Name
- Dilapan-S
- Primary DI
- 08595231700284
- Version / Model
- DS355
- Catalog Number
- 3x55 mm
- Company Name
- MEDICEM Technology s.r.o.
- Labeler DUNS
- 496847310
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-05-01
- Public Version
- 5
- Public Version Date
- 2023-02-20
- Public Version Status
- Update
- Public Device Record Key
- 86c59eb4-0fcf-4d24-ae2a-5a298e36ff84
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
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PKN | Dilator, Cervical, Synthetic, Osmotic | Obstetrics/Gynecology | 884.4260 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 08595231700291 | GS1 | box | 10 | Not in Commercial Distribution | 2023-02-20 |
| Primary | 08595231700284 | GS1 | ||||
| Package | 08595231700307 | GS1 | box | 25 | Not in Commercial Distribution | 2023-02-20 |
| Package | 08595231703094 | GS1 | box | 10 | In Commercial Distribution | |
| Package | 08595231703100 | GS1 | box | 25 | In Commercial Distribution |
Customer Contacts
- Phone
- 540-3759380
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K143447 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 3 | Millimeter | |
| Length | 55 | Millimeter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from sun
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep in a dry place
- Type
- Handling Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius