FDA UDI
In Commercial Distribution
🇺🇸 United States
BIOPSY DIGIT
DI: 08033837190219
·
Model: BIOPSY DIGIT AM
·
I.M.S. INTERNAZIONALE MEDICO SCIENTIFICA SRL
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- BIOPSY DIGIT
- Primary DI
- 08033837190219
- Version / Model
- BIOPSY DIGIT AM
- Catalog Number
- 9100-01
- Company Name
- I.M.S. INTERNAZIONALE MEDICO SCIENTIFICA SRL
- Labeler DUNS
- 429113525
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-22
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 6dd542fb-d069-42ff-9a28-323e1eedea65
Device Description
Biopsy Digit device uses two stereo images taken by a digital solid state camera to determine the location of a lesion in three dimensions. It is intended to mammographic procedures requiring stereotactic guidance, such as fine needle aspiration, needle biopsy and guide wire placement.
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
- Labeling does not contain MRI Safety Information
- 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 |
|---|---|---|---|---|
| IZH | System, X-Ray, Mammographic | Radiology | 892.1710 | 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 |
|---|---|---|---|---|---|---|
| Package | 18033837190216 | GS1 | N006643 | 1 | In Commercial Distribution | |
| Primary | 08033837190219 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K990192 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Height | 347 | Millimeter | |
| Depth | 303 | Millimeter | |
| Width | 350 | Millimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 70 Degrees Celsius