AccessGUDID - DEVICE: Salibag Disposable Pouch for CCD/SLB-LL (D2486562331)

GUDID

Device Identifier (DI) Information

Brand Name: Salibag Disposable Pouch for CCD/SLB-LL
Version or Model: 656233
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: HAGER WORLDWIDE, INC.

Primary DI Number: D2486562331
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 240
Labeler D-U-N-S® Number*: 009277971 *Terms of Use

Device Description: Protective Hygienic pouches for sensors and conventional films

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:	Yes
Prescription Use (Rx):	No
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?
62743	Sensor holder, single-use	A device designed to hold (house) a sensor so that it is fixed (locked) in a stable position, including adhesive fixation. It will then allow for the holder and the attached sensor to be fastened to, e.g., the patient's body, another device, or a suitable place in the vicinity of use. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EGZ	Holder, film, x-ray

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: 26f8d20b-01b0-4cb4-8688-170ae58dd1c1
Public Version Date: September 20, 2023
Public Version Number: 1
DI Record Publish Date: September 12, 2023