FDA UDI
In Commercial Distribution
🇺🇸 United States
MPM Medical Supply (Private Label)
DI: 00859013006017
·
Model: KOP2003
·
MANAN MEDICAL PRODUCTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- MPM Medical Supply (Private Label)
- Primary DI
- 00859013006017
- Version / Model
- KOP2003
- Catalog Number
- KOP2003
- Company Name
- MANAN MEDICAL PRODUCTS, INC.
- Labeler DUNS
- 831737957
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-01-05
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 9213a9e8-301f-43e5-8788-7d5b656daa56
Device Description
20GA X 3 CM (Breast Localization Needle With Two Wires)
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
- 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
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GAA | Needle, Aspiration And Injection, Disposable | General, Plastic Surgery | 878.4800 | 1 |
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 | 20859013006011 | GS1 | Unit Boxes | 10 | In Commercial Distribution | |
| Package | 10859013006014 | GS1 | Tyvek Pouch | 10 | In Commercial Distribution | |
| Primary | 00859013006017 | GS1 |
Customer Contacts
- Phone
- 224-625-8331
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K863848 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 3 | Centimeter |