FDA UDI
In Commercial Distribution
🇺🇸 United States
BIOPSYBELL
DI: 08033860036638
·
Model: BONE MARROW MSC ASPIRATION KIT Marrow-Kit
·
BIOPSYBELL SRL
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- BIOPSYBELL
- Primary DI
- 08033860036638
- Version / Model
- BONE MARROW MSC ASPIRATION KIT Marrow-Kit
- Catalog Number
- MAK1310C-US
- Company Name
- BIOPSYBELL SRL
- Labeler DUNS
- 438746708
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-12-22
- Public Version
- 1
- Public Version Date
- 2021-12-30
- Public Version Status
- New
- Public Device Record Key
- b7b1a304-ae45-45cb-81d7-8ffbc6b72759
Device Description
ASPIRATION/EXPLANT OF BONE MARROW THROUGH A PISTON SYRINGE
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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 |
|---|---|---|---|---|
| 47612 | Bone marrow explant needle | A sterile, sharp bevel-edged, hollow tubular metal instrument designed to percutaneously explant bone marrow (explant is the collection and transfer of living bone marrow from its natural site to a new site, or to a culture medium). The device is typically available in a variety of large bores, and is sufficiently robust to penetrate bone (usually the sternum, hip bone, or posterior iliac crest) with the force of pressure and twisting manually applied to its proximal handgrip. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08033860036638 | GS1 |
Customer Contacts
- Phone
- +39053527850
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K203397 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Needle Gauge | 13 | Gauge | |
| Length | 100 | Millimeter |