AccessGUDID - DEVICE: Exact Medical Manufacturing, Inc. (00850033380880)

GUDID

Device Identifier (DI) Information

Brand Name: Exact Medical Manufacturing, Inc.
Version or Model: E6558N
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: E6558N
Company Name: EXACT MEDICAL MANUFACTURING, INC.

Primary DI Number: 00850033380880
Issuing Agency: GS1
Commercial Distribution End Date: October 03, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 014464314 *Terms of Use

Device Description: Sponge Counter Bag Rack

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:	No
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?
13693	Surgical sponge-counting rack	A device in the form of a vertically-mounted rack intended to be used in the operating room (OR) to maintain the count of surgical sponges/swabs during a surgical procedure, typically to prevent these items from being inadvertently left in a patient. It is a rack/holder with hooks/pockets upon which soiled sponges/swabs may be arranged; it may be used in conjunction with an associated counting bag (not included). This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LYU	Accessory, Surgical Apparel

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 165b7d62-c511-4eae-9d1d-10eb13c9fc8b
Public Version Date: October 04, 2024
Public Version Number: 2
DI Record Publish Date: December 09, 2021