FDA UDI
In Commercial Distribution
🇺🇸 United States
Mammotome MR
DI: 00841911101086
·
Model: MRU08S
·
DEVICOR MEDICAL PRODUCTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Mammotome MR
- Primary DI
- 00841911101086
- Version / Model
- MRU08S
- Company Name
- DEVICOR MEDICAL PRODUCTS, INC.
- Labeler DUNS
- 961832156
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-25
- Public Version
- 4
- Public Version Date
- 2022-02-07
- Public Version Status
- Update
- Public Device Record Key
- 7d9498b5-61b7-455d-a8d5-1d49d2cec33d
Device Description
Universal Targeting Set - Short
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
- MR Conditional
- 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 |
|---|---|---|---|---|
| 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 | 00841911101086 | GS1 | ||||
| Package | 10841911101083 | GS1 | 1 | In Commercial Distribution |
Customer Contacts
- Phone
- 877-926-2666
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K042753 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 115 | Millimeter | |
| Needle Gauge | 8 | Gauge |