FDA UDI
In Commercial Distribution
🇺🇸 United States
DEFINITY CERVICAL DILATOR, 5MM
DI: 15420045512412
·
Model: DCD-501
·
Hologic, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
5
Pkg Device Count
1
Basic Information
- Brand Name
- DEFINITY CERVICAL DILATOR, 5MM
- Primary DI
- 15420045512412
- Version / Model
- DCD-501
- Catalog Number
- DCD-501
- Company Name
- Hologic, Inc.
- Labeler DUNS
- 018925968
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-02-05
- Public Version
- 1
- Public Version Date
- 2020-02-13
- Public Version Status
- New
- Public Device Record Key
- f91bd609-8472-4f5f-a606-95a0b06f941d
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- Yes
- 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
- Yes
- Sterilization Methods
- Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PON | Catheter, balloon, dilation of cervical canal | Obstetrics/Gynecology | 884.4260 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47126 | Cervical dilatation catheter | A flexible, tube-like device, typically with two or more inflatable balloons at the distal working end, designed to dilate (stretch open) the cervical canal after insertion through the cervical os and expansion of the balloons to assist in obstetrical or gynaecological procedures. It may be used for labour induction, spontaneously occurring labour, non-progressive labour, cervical dystocia, undesirable prolonged uterine contractions, and intrauterine foetal death (IUFD) where delivery of the foetus is difficult. Such procedures may be performed at or prior to full-term pregnancy. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 35420045512416 | GS1 | BOX | 5 | In Commercial Distribution | |
| Package | 25420045512419 | GS1 | BOX | 5 | In Commercial Distribution | |
| Primary | 15420045512412 | GS1 | ||||
| Package | 35420045512447 | GS1 | BOX | 1 | In Commercial Distribution | |
| Package | 25420045512440 | GS1 | BOX | 1 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K190813 | 000 |