AccessGUDID - DEVICE: Contact guard (EyeMag Pro F/S) (04049539103680)

GUDID

Device Identifier (DI) Information

Brand Name: Contact guard (EyeMag Pro F/S)
Version or Model: 304156-0400-810
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Carl Zeiss Meditec AG

Primary DI Number: 04049539103680
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 342228620 *Terms of Use

Device Description: No description.

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?
58976	Medical equipment/instrument drape, reusable	A noninvasive flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment/instrument (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the equipment/instrument from soiling and/or contamination when used inside, or within the vicinity, of a hygienic area. It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PUI	Drape, Surgical, Exempt

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: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ad1a3223-bdb9-47aa-8530-e370295939c2
Public Version Date: September 11, 2024
Public Version Number: 2
DI Record Publish Date: March 31, 2023