FDA UDI
In Commercial Distribution
🇺🇸 United States
MC-RAN-11CX Bone Marrow Aspiration Needle
DI: 00858690006334
·
Model: 11 Gauge X 3.5"
·
RANFAC CORP.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- MC-RAN-11CX Bone Marrow Aspiration Needle
- Primary DI
- 00858690006334
- Version / Model
- 11 Gauge X 3.5"
- Catalog Number
- MC-RAN-11CX
- Company Name
- RANFAC CORP.
- Labeler DUNS
- 121622872
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-27
- Public Version
- 4
- Public Version Date
- 2021-10-19
- Public Version Status
- Update
- Public Device Record Key
- f2808230-c7af-46a5-96c2-0a6cb859cb69
Device Description
MC-RAN-11CX Bone Marrow Aspiration Needle, 11GA X 3.5" P/N 74287-01M
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- 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
- 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 |
|---|---|---|---|---|
| 60478 | Bone access cannula | A sterile, sharp, hollow tubular metal instrument designed for percutaneous insertion to provide access to any bone of the body for a bone biopsy needle or guidewire, or for a bone marrow aspiration technique, or for inserting therapeutic materials, including bone cements. It is typically inserted using a stylet under imaging [e.g., fluoroscopic, ultrasonic, computed tomography (CT)] control and has a proximal plastic handgrip to apply manual pressure and twist. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00858690006334 | GS1 | ||||
| Package | 10858690006331 | GS1 | INNER PACK | 1 | In Commercial Distribution | |
| Package | 20858690006338 | GS1 | CASE | 30 | In Commercial Distribution |
Customer Contacts
- Phone
- 5085884400
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K150563 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 3.5 | Inch | |
| Needle Gauge | 11 | Gauge |