LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy) 20085

GUDID 10853277008098

LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy)

UVISION 360, INC.

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)