AccessGUDID - DEVICE: PROVEO 8 Optics Carrier (07630003581799)

GUDID

Device Identifier (DI) Information

Brand Name: PROVEO 8 Optics Carrier
Version or Model: 000000000010448800
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Leica Microsystems (Schweiz) AG

Primary DI Number: 07630003581799
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 480198725 *Terms of Use

Device Description: PROVEO Optics Carrier - for Leica surgical operating microscope systems: PROVEO 8

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":	No
For Single-Use:	No
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?
32817	Ophthalmic slit lamp, surgical	An electrically-powered ophthalmic magnification instrument, usually stereoscopic, designed for use in the operating room (OR) to magnify minute structures within the eye or its surroundings in the performance of ophthalmic surgical procedures which require high magnification by transmitted light. It is typically equipped with motorized focusing, adjustable magnification mechanisms (zoom), backup lamps, and inclined tubes that permit the surgeon to see the field from a vertical perspective while keeping the head erect. Dual or multiple observation capability and the optical integration of still, motion picture and video cameras are common features. It can be fixed or mobile.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
HRM	MICROSCOPE, OPERATING & ACCESSORIES, AC-POWERED, OPHTHALMIC

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify:

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify:

Device Record Status

Public Device Record Key: 1ecc5492-3621-48e2-9d2d-29a20b4f0ab3
Public Version Date: April 08, 2022
Public Version Number: 2
DI Record Publish Date: September 22, 2020