FDA UDI
In Commercial Distribution
🇺🇸 United States
BMP Medical Tissue Grinder (Vitrified Tip)
DI: 00853778007111
·
Model: BMP-TG-708
·
Biomedical Polymers, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- BMP Medical Tissue Grinder (Vitrified Tip)
- Primary DI
- 00853778007111
- Version / Model
- BMP-TG-708
- Company Name
- Biomedical Polymers, Inc.
- Labeler DUNS
- 037687837
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-08-21
- Public Version
- 1
- Public Version Date
- 2023-08-29
- Public Version Status
- New
- Public Device Record Key
- 0db4c7a7-0be3-4481-857c-4a0f36e9ac8e
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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LEC | Grinder, Tissue | Pathology | 864.3010 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57857 | Tissue processor IVD, manual | A manual laboratory instrument intended to be used for the processing of clinical tissue specimens [e.g., fixation (encapsulation in paraffin wax), dehydration, infiltration] in preparation for subsequent cytological or histological examination. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10853778007118 | GS1 | Case | 10 | In Commercial Distribution | |
| Primary | 00853778007111 | GS1 |