LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy) 20085

GUDID 10853277008098

LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy)

UVISION 360, INC.

Endometrial biopsy curette Endometrial biopsy curette Endometrial biopsy curette Endometrial biopsy curette Endometrial biopsy curette Endometrial biopsy curette Endometrial biopsy curette Endometrial biopsy curette

• Primary Device ID: 10853277008098
• NIH Device Record Key: ef281179-81d9-479e-be7f-ee0468708ca0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy)
• Version Model Number: LUMBx-360 DOWN
• Catalog Number: 20085
• Company DUNS: 080826327
• Company Name: UVISION 360, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00853277008091 [Primary]
GS1	10853277008098 [Package]; Contains: 00853277008091; Package: pouch [5 Units]; In Commercial Distribution
GS1	20853277008095 [Package]; Contains: 00853277008091; Package: case [30 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210512

FDA Product Code

• HIH: Hysteroscope (And Accessories)

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[10853277008098]

Ethylene Oxide

[10853277008098]

Ethylene Oxide

[10853277008098]

Ethylene Oxide

[10853277008098]

Ethylene Oxide

[10853277008098]

Ethylene Oxide

[10853277008098]

Ethylene Oxide

[10853277008098]

Ethylene Oxide

[10853277008098]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-08-23
• Device Publish Date: 2021-08-13

On-Brand Devices [LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy)]

• 10853277008098: LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy)
• 10853277008081: LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy)