FDA UDI
In Commercial Distribution
🇺🇸 United States
Midwest Medical Inc. (Private Label)
DI: 00859013006048
·
Model: CNM2206-MM
·
MANAN MEDICAL PRODUCTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Midwest Medical Inc. (Private Label)
- Primary DI
- 00859013006048
- Version / Model
- CNM2206-MM
- Catalog Number
- CNM2206-MM
- Company Name
- MANAN MEDICAL PRODUCTS, INC.
- Labeler DUNS
- 831737957
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-21
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- f7563c5c-9487-467a-9ee7-adc5bb663861
Device Description
22 GA x 15CM MARKED CHIBA NEEDLE
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 |
|---|---|---|---|---|
| KNW | Instrument, Biopsy | Gastroenterology, Urology | 876.1075 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47540 | Soft-tissue biopsy needle, single-use | A sterile, sharp bevel-edged, hollow tubular metal instrument designed to percutaneously obtain a specimen of soft tissue, typically for histopathological examination. The device is usually attached to a syringe for the aspiration of the specimen; it is available in a variety of lengths, diameters (bores), and tip configurations (e.g., straight or curved). This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20859013006042 | GS1 | Shipper Box | 10 | In Commercial Distribution | |
| Package | 10859013006045 | GS1 | Unit Boxes | 10 | In Commercial Distribution | |
| Primary | 00859013006048 | GS1 |
Customer Contacts
- Phone
- 224-625-8331
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K851838 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 15 | Centimeter |