FDA UDI
In Commercial Distribution
🇺🇸 United States
LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy)
DI: 00853277008091
·
Model: LUMBx-360 DOWN
·
UVISION 360, INC.
Product Codes
4
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy)
- Primary DI
- 00853277008091
- Version / Model
- LUMBx-360 DOWN
- Catalog Number
- 20085
- Company Name
- UVISION 360, INC.
- Labeler DUNS
- 080826327
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-08-13
- Public Version
- 1
- Public Version Date
- 2021-08-23
- Public Version Status
- New
- Public Device Record Key
- ef281179-81d9-479e-be7f-ee0468708ca0
Device Description
LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy)
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
- 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
- No
- 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 |
|---|---|---|---|---|
| HIH | Hysteroscope (And Accessories) | Obstetrics/Gynecology | 884.1690 | 2 |
| FAJ | Cystoscope And Accessories, Flexible/Rigid | Gastroenterology, Urology | 876.1500 | 2 |
| HFF | Aspirator, Endometrial | Obstetrics/Gynecology | 884.1060 | 2 |
| FCK | Instrument, Biopsy, Suction | Gastroenterology, Urology | 876.1075 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46871 | Endometrial biopsy curette | A hand-held, surgical instrument used to for the removal of small amounts of endometrial secretions and/or tissue from the uterus for biopsy purposes. It is typically made of high-grade stainless steel and is available in a variety of designs: 1) a long, thin, instrument with very small spoon-like scoop terminating at either end and a centrally placed handle; 2) a long, thin tubular device with a serrated opening at the distal end and a connection to a suction device or a syringe at the proximal end; or 3) a single-ended device with a scraper at the distal end. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10853277008098 | GS1 | pouch | 5 | In Commercial Distribution | |
| Primary | 00853277008091 | GS1 | ||||
| Package | 20853277008095 | GS1 | case | 30 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K210512 | 000 |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 0 – 95 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -10 – 60 Degrees Fahrenheit