AccessGUDID - DEVICE: Exact Medical Manufacturing, Inc. (00850033380835)

GUDID

Device Identifier (DI) Information

Brand Name: Exact Medical Manufacturing, Inc.
Version or Model: E6451
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: E6451
Company Name: EXACT MEDICAL MANUFACTURING, INC.

Primary DI Number: 00850033380835
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: Probe Cover, VIP film, Gel, Elastic bands 15x91cm - 6"x36"

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?
44713	Body-surface ultrasound imaging transducer cover	A device/material intended to be used as a physical barrier for protection against the effects of environmental exposure (e.g., body fluids, gels) and/or to maintain the required hygienic level of an ultrasound system imaging transducer (probe) used on the body surface during an ultrasound examination. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ITX	Transducer, Ultrasonic, Diagnostic

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: 286072f7-0ee4-4185-9f7d-b297bb26c793
Public Version Date: October 04, 2024
Public Version Number: 2
DI Record Publish Date: December 07, 2021

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
00850033380842	20	00850033380835	2024-10-03	Not in Commercial Distribution	Inner Case
00850033380859	3	00850033380842	2024-10-03	Not in Commercial Distribution	Case