AccessGUDID - DEVICE: Exact Medical Manufacturing, Inc. (00816953024501)

GUDID

Device Identifier (DI) Information

Brand Name: Exact Medical Manufacturing, Inc.
Version or Model: E5929
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: EXACT MEDICAL MANUFACTURING, INC.

Primary DI Number: 00816953024501
Issuing Agency: GS1
Commercial Distribution End Date: September 30, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 014464314 *Terms of Use

Device Description: C-Pouch Drape, One Piece 267x152cm - 105"x60"

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):	Yes
Device labeled as "Not made with natural rubber latex":	No
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
KKX	Drape, Surgical

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No 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: dc1fcd0f-5119-44bb-82a2-f7cb29f82018
Public Version Date: October 01, 2024
Public Version Number: 4
DI Record Publish Date: November 13, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
00816953024518	20	00816953024501	2024-09-30	Not in Commercial Distribution	Inner Case
00816953024525	40	00816953024501	2024-09-30	Not in Commercial Distribution	Case