FDA UDI
In Commercial Distribution
🇺🇸 United States
MAXX-REGEN
DI: 00857878007033
·
Model: 11GA X 11CM
·
RANFAC CORP.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- MAXX-REGEN
- Primary DI
- 00857878007033
- Version / Model
- 11GA X 11CM
- Catalog Number
- RB-REG-3
- Company Name
- RANFAC CORP.
- Labeler DUNS
- 121622872
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-06-17
- Public Version
- 1
- Public Version Date
- 2019-06-25
- Public Version Status
- New
- Public Device Record Key
- f1b6a6bd-d701-4f21-b7c3-5c8c89ccae4f
Device Description
MAXX-REGEN Bone Marrow Aspirate Kit w/ Bone Harvester 11GA X 11CM MC-RAN-11CSTS 8GA X 10CM RJN-810 Customer # 0018407 PN 74292-03M
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
- 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 |
|---|---|---|---|---|---|---|
| Package | 20857878007037 | GS1 | Case | 30 | In Commercial Distribution | |
| Package | 10857878007030 | GS1 | Inner | 1 | In Commercial Distribution | |
| Primary | 00857878007033 | GS1 |
Customer Contacts
- Phone
- 5085884400
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K150563 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 10 | Centimeter | |
| Needle Gauge | 8 | Gauge | |
| Length | 11 | Centimeter | |
| Needle Gauge | 11 | Gauge |