AccessGUDID - DEVICE: LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy) (00853277008084)

GUDID

Device Identifier (DI) Information

Brand Name: LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy)
Version or Model: LUMBx-360 UP
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 20080
Company Name: UVISION 360, INC.

Primary DI Number: 00853277008084
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080826327 *Terms of Use

Device Description: LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy)

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HIH	Hysteroscope (And Accessories)
FAJ	Cystoscope And Accessories, Flexible/Rigid
HFF	Aspirator, Endometrial
FCK	Instrument, Biopsy, Suction

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K210512	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between -10 and 60 Degrees Fahrenheit
Handling Environment Humidity: between 0 and 95 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6a1cd7d9-d09a-4f8d-836b-f3a05a913c9f
Public Version Date: August 23, 2021
Public Version Number: 1
DI Record Publish Date: August 13, 2021