FDA UDI
In Commercial Distribution
🇺🇸 United States
EnCor EnCompass™
DI: 00801741234262
·
Model: ENCPFS
·
Bard Peripheral Vascular, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- EnCor EnCompass™
- Primary DI
- 00801741234262
- Version / Model
- ENCPFS
- Catalog Number
- ENCPFS
- Company Name
- Bard Peripheral Vascular, Inc.
- Labeler DUNS
- 135057938
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-02-03
- Public Version
- 1
- Public Version Date
- 2026-02-11
- Public Version Status
- New
- Public Device Record Key
- eec636f9-939d-48c5-a6ad-2d284e0a9510
Device Description
EnCor EnCompass™ Breast Biopsy and Tissue Removal System Foot Switch
Device Characteristics
- Single Use
- No
- 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
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- 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 |
|---|---|---|---|---|
| 36190 | Mammographic stereotactic biopsy system | An assembly of devices intended to be used in conjunction with mammography to insert biopsy devices, typically designated needles, into a breast in order to extract a biopsy of a suspect tumour for diagnostic purposes. It consists of a biopsy unit with needle guides, needles, an examination table, and an integral computer for communicating lesion coordinates. This GMDN code includes stand-alone units as well as units that mount onto an existing mammographic radiographic unit. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00801741234262 | GS1 |
Customer Contacts
- Phone
- +1(800)321-4254
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K252681 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry
- Type
- Special Storage Condition, Specify
- Special Conditions
- Atmospheric pressure limitation 500 -1060 hPa
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from sunlight
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do Not Immerse in Any Liquid
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 90 Percent (%) Relative Humidity
- Type
- Special Storage Condition, Specify
- Special Conditions
- For Indoor Use Only
- Type
- Storage Environment Temperature
- Temperature Range
- -18 – 40 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Wipe with Damp Cloth