FDA UDI
In Commercial Distribution
🇺🇸 United States
Dilator/ Sound Set
DI: 00888937016734
·
Model: MX21
·
Coopersurgical, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Dilator/ Sound Set
- Primary DI
- 00888937016734
- Version / Model
- MX21
- Company Name
- Coopersurgical, Inc.
- Labeler DUNS
- 801895244
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-11-10
- Public Version
- 3
- Public Version Date
- 2024-02-28
- Public Version Status
- Update
- Public Device Record Key
- 0a5dec2c-ff58-4bac-b693-54b3eaa7dd18
Device Description
Dilator/ Sound Set
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
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- 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 |
|---|---|---|---|---|
| HHM | Sound, Uterine | Obstetrics/Gynecology | 884.4530 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47987 | Fixed-diameter cervical dilator, single-use | A rod-like, solid surgical instrument designed to dilate the cervical canal after its insertion through the cervical os. Commonly known as a uterine dilator, it is typically made of metal or plastic material and has a tapered, rounded distal tip. It may have one diameter or two different size diameters, one at each end of the instrument. The device is typically available in a set of graduated sizes that are applied in succession. It is used to allow the passage of a curette or other instruments into the uterus and/or enlarge the uterus prior to surgical intervention by pressing on the inner walls of the uterus. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20888937016738 | GS1 | 2 | 10 | In Commercial Distribution | |
| Primary | 00888937016734 | GS1 |