FDA UDI
In Commercial Distribution
🇺🇸 United States
BioSentry®
DI: 00884450808122
·
Model: A
·
Merit Medical Systems, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- BioSentry®
- Primary DI
- 00884450808122
- Version / Model
- A
- Catalog Number
- H787768022019S1
- Company Name
- Merit Medical Systems, Inc.
- Labeler DUNS
- 184763290
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-03-14
- Public Version
- 1
- Public Version Date
- 2024-03-22
- Public Version Status
- New
- Public Device Record Key
- 710e6932-423e-4d27-b384-7791d9b7930c
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
- 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 |
|---|---|---|---|---|
| OMT | Absorbable lung biopsy plug | General, Plastic Surgery | 878.4755 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38562 | Lung biopsy procedure kit | A collection of sterile devices designed to perform a histologic specimen aspiration during a percutaneous lung biopsy. It typically includes a biopsy needle and other supplies to perform this procedure. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00884450808122 | GS1 |