FDA UDI
In Commercial Distribution
🇺🇸 United States
Vitruvian Infiltration Pump
DI: B089B890550
·
Model: B89055
·
BLACK & BLACK SURGICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Vitruvian Infiltration Pump
- Primary DI
- B089B890550
- Version / Model
- B89055
- Catalog Number
- B89055
- Company Name
- BLACK & BLACK SURGICAL, INC.
- Labeler DUNS
- 004382282
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-07-03
- Public Version
- 5
- Public Version Date
- 2023-01-23
- Public Version Status
- Update
- Public Device Record Key
- 0f251c9b-388b-4257-9572-54ef6e45a8cd
Device Description
VITRUVIAN INFILTRATION PUMP; LED VOLUME DISPLAY - VARIABLE SPEED HIGH FLOW, 100-240VAC
Device Characteristics
- Single Use
- No
- 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
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MUU | System, Suction, Lipoplasty | General, Plastic Surgery | 878.5040 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36894 | Liposuction system | An assembly of devices designed specifically to aspirate subcutaneous fat from the body by means of suction during a liposuction/lipectomy procedure. The system consists of an electrically-powered suction pump, typically with collection containers, tubing, and microbial/hydrophobic filters, and includes patient contact devices (e.g., handpiece/tip, cannula). The pump generates negative pressure for aspiration of fat through the patient contact device, which is inserted subcutaneously into the fat layer, and into the collection containers. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B089B890550 | HIBCC | ||||
| Secondary | 00840329829162 | GS1 |
Customer Contacts
- Phone
- 1-877-252-2517
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K170629 | 000 |