AccessGUDID - DEVICE: MedSource Tracheostomy Hook (00840155408852)

GUDID

Device Identifier (DI) Information

Brand Name: MedSource Tracheostomy Hook
Version or Model: MS-29100
Commercial Distribution Status: In Commercial Distribution
Catalog Number: Not Applicable
Company Name: MEDSOURCE INTERNATIONAL LLC

Primary DI Number: 00840155408852
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 041674552 *Terms of Use

Device Description: MedSource Tracheostomy Hook

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):	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?
63973	Tracheal surgery dilator, single-use	A sterile, hand-held, manual surgical instrument intended to be used during surgical intervention of the trachea to dilate tracheal structures/passages, typically during the creation of a tracheostoma and/or for expanding the margins of a tracheostoma to assist in the insertion of a tracheostomy tube. It may be in the form of a slender hollow or solid cylinder or a scissors-like instrument. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MDM	Instrument, Manual, Surgical, General Use

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: a7e4c669-f1bf-4ce4-81d8-30f202029ee9
Public Version Date: June 30, 2021
Public Version Number: 1
DI Record Publish Date: June 22, 2021