FDA UDI
Not in Commercial Distribution
🇺🇸 United States
EnCor®
DI: 00801741086373
·
Model: ECSTUS0112G
·
SENORX, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- EnCor®
- Primary DI
- 00801741086373
- Version / Model
- ECSTUS0112G
- Catalog Number
- ECSTUS0112G
- Company Name
- SENORX, INC.
- Labeler DUNS
- 043674543
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-20
- Public Version
- 5
- Public Version Date
- 2024-04-17
- Public Version Status
- Update
- Public Device Record Key
- 8935564f-081a-4d49-a760-98ad84e1bbdd
- Distribution End Date
- 2023-09-28
Device Description
EnCor® Ultrasound Stylet and Coaxial, 12G
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
- 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 |
|---|---|---|---|---|
| GEI | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | General, Plastic Surgery | 878.4400 | 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 | 10801741086370 | GS1 | CA | 5 | Not in Commercial Distribution | 2023-09-28 |
| Primary | 00801741086373 | GS1 |
Customer Contacts
- Phone
- +1(800)321-4254
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 12, Gauge |