FDA UDI
In Commercial Distribution
🇺🇸 United States
Bone Marrow Aspirate Kit
DI: 00810131881887
·
Model: BMANS-09
·
SURGENTEC, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Bone Marrow Aspirate Kit
- Primary DI
- 00810131881887
- Version / Model
- BMANS-09
- Company Name
- SURGENTEC, LLC
- Labeler DUNS
- 004095409
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-03-09
- Public Version
- 1
- Public Version Date
- 2026-03-17
- Public Version Status
- New
- Public Device Record Key
- 5c33b66b-cbaf-4bff-8204-dd3c94e2fda5
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
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| PDQ | Neurosurgical Nerve Locator | Ear, Nose, Throat | 874.1820 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61140 | Blood cell harvesting system | An assembly of non-powered sterile devices intended to be used to concentrate and collect nucleated cells, platelets, or bone marrow aspirate cells, from a volume of the patient's own blood/bone marrow, for human cell therapy. It typically includes flexible bags, tubing with slide clamps, and a filter to capture the target cells which are subsequently flushed using a harvest solution (not included) into a collection vessel. It is intended to be used at the point-of-care during a procedure, or in a laboratory. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810131881887 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K243945 | 000 |