FDA UDI
In Commercial Distribution
🇺🇸 United States
CorVocet™
DI: 00884450316740
·
Model: 00884450316740
·
Merit Medical Systems, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- CorVocet™
- Primary DI
- 00884450316740
- Version / Model
- 00884450316740
- Catalog Number
- CORCA1815SB/A
- Company Name
- Merit Medical Systems, Inc.
- Labeler DUNS
- 184763290
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-05-24
- Public Version
- 3
- Public Version Date
- 2021-10-11
- Public Version Status
- Update
- Public Device Record Key
- 526356f4-8889-4ab6-850b-87b3ae6170f1
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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 |
|---|---|---|---|---|
| KNW | INSTRUMENT, BIOPSY | Gastroenterology, Urology | 876.1075 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16835 | Soft-tissue biopsy procedure kit, non-medicated | A collection of sterile devices designed to perform a non-specific soft tissue biopsy. It includes the biopsy needle used for this procedure; it does not include a pharmaceutical. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10884450316747 | GS1 | 5 | In Commercial Distribution | ||
| Primary | 00884450316740 | GS1 | ||||
| Package | 20884450316744 | GS1 | 4 | In Commercial Distribution |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Coaxial Length (cm)-9.5 cm | ||
| Device Size Text, specify | Biopsy Device Gauge-18G | ||
| Device Size Text, specify | Biopsy Device Length (cm)-15.0 cm | ||
| Device Size Text, specify | Coaxial Gauge-17G |