FDA UDI
In Commercial Distribution
🇺🇸 United States
BIOPSYBELL
DI: 08033860025083
·
Model: OSTEOBELL EXPLANT
·
BIOPSYBELL SRL
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- BIOPSYBELL
- Primary DI
- 08033860025083
- Version / Model
- OSTEOBELL EXPLANT
- Catalog Number
- OBE0815T
- Company Name
- BIOPSYBELL SRL
- Labeler DUNS
- 438746708
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-03-31
- Public Version
- 4
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- a92686aa-66b4-4ba8-aed9-dc0d02b8d281
Device Description
NEEDLE FOR BONE MARROW EXPLANT
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
- 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 |
|---|---|---|---|---|
| FCG | Biopsy Needle | Gastroenterology, Urology | 876.1075 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16835 | Soft-tissue biopsy procedure kit, non-medicated | A collection of sterile devices designed to perform a non-specific soft tissue biopsy. It includes the biopsy needle used for this procedure; it does not include a pharmaceutical. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 08033860025106 | GS1 | BLISTER | 5 | In Commercial Distribution | |
| Primary | 08033860025083 | GS1 |
Customer Contacts
- Phone
- +39053527850
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K130616 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 150 | Millimeter | |
| Needle Gauge | 8 | Gauge |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 5 – 30 Degrees Celsius