AccessGUDID - DEVICE: GLASSCOCK® EAR DRESSING, PEDIATRIC (00850000126022)

GUDID

Device Identifier (DI) Information

Brand Name: GLASSCOCK® EAR DRESSING, PEDIATRIC
Version or Model: S-1003
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Oto-Med, Inc.

Primary DI Number: 00850000126022
Issuing Agency: GS1
Commercial Distribution End Date: December 15, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 059817742 *Terms of Use

Device Description: GLASSCOCK® EAR DRESSING, PEDIATRIC

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):	Yes
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?
34084	Wound compression dressing	A sterile covering designed to exert pressure on a wounded area to prevent the collection of fluids in the underlying tissues; most commonly used after skin grafting and in the treatment of burns. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MHW	Dressing, Compression

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: 09fdab03-fd2c-420f-82e6-8912f541da16
Public Version Date: December 22, 2020
Public Version Number: 3
DI Record Publish Date: September 21, 2018