AccessGUDID - DEVICE: Exact Medical Manufacturing, Inc. (00852205007922)

GUDID

Device Identifier (DI) Information

Brand Name: Exact Medical Manufacturing, Inc.
Version or Model: EP5513
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: EP5513
Company Name: EXACT MEDICAL MANUFACTURING, INC.

Primary DI Number: 00852205007922
Issuing Agency: GS1
Commercial Distribution End Date: October 02, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 014464314 *Terms of Use

Device Description: Microscope Drape, Leica 137x381cm – 54” x 150”

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):	No
Over the Counter (OTC):	Yes
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?
12535	Medical equipment/instrument drape, single-use	A 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 may have patient contact, however it is not intended to be introduced into a body cavity (noninvasive). It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HMW	Drape, Microscope, 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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

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: 53dc9814-5461-4bae-bcac-98ea2a8584a5
Public Version Date: October 03, 2024
Public Version Number: 3
DI Record Publish Date: October 24, 2017

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
00852205007946	1	00852205007939	2024-10-02	Not in Commercial Distribution	Case
00852205007939	16	00852205007922	2024-10-02	Not in Commercial Distribution	Inner Case