FDA UDI
In Commercial Distribution
🇺🇸 United States
Cook
DI: 00827002190276
·
Model: G19027
·
COOK INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Cook
- Primary DI
- 00827002190276
- Version / Model
- G19027
- Catalog Number
- J-CVS-532400
- Company Name
- COOK INCORPORATED
- Labeler DUNS
- 042823948
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2014-09-24
- Public Version
- 4
- Public Version Date
- 2020-03-05
- Public Version Status
- Update
- Public Device Record Key
- b1a871f2-dd28-46fe-9306-76d4f52ee174
Device Description
Cook, Chorionic Villus Sampling 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
- 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
- Yes
- 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 |
|---|---|---|---|---|
| LLX | CATHETER, SAMPLING, CHORIONIC VILLUS | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 18105 | Chorionic villus sampling catheter | A sterile flexible tube designed for transcervical chorionic villus sampling (CVS) to obtain intrauterine specimens of the chorioinic villi for genetic testing to detect chromosomal disorders in the foetus during the first trimester of pregnancy. The device usually includes a malleable, preshaped stylet, and is usually introduced under ultrasonographic guidance via the vagina/cervix. The suction for sampling is provided by an external syringe. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00827002190276 | GS1 |
Customer Contacts
- Phone
- +1(812)330-5494
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P900007 | 002 |
| P900007 | 004 |
| P900007 | 005 |
| P900007 | 006 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in dark, dry, cool place.