AccessGUDID - DEVICE: ELMED (00842180149571)

GUDID

Device Identifier (DI) Information

Brand Name: ELMED
Version or Model: 40-0613
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 40-0613
Company Name: ELMED INCORPORATED

Primary DI Number: 00842180149571
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 049290364 *Terms of Use

Device Description: ZEITEL STYLE ORAL-TRACHEAL VOCAL CORD INJECTION NEEDLE. ANGLED UP 25GA. NEEDLE, 20CM WORKING LENGTH, 3.5MM REDUCED TO 1.2MM AT TIP.

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:	No
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?
35085	Mouth gag, adjustable, reusable	A mechanical device with adjustable parts intended to be placed between the teeth of the upper and lower jaws of a patient to maintain an open oral cavity, typically during emergent placement of an artificial airway or for an oral/dental surgical intervention. Also known as a jaw spreader, it is available in various designs having support structures that force and/or hold the jaws apart; e.g., it may be designed with flat, pivoted blades that angle outward when adjusted; or it may have two parallel plates that move apart with adjustments to a centre screw; or it may have a scissors-like design with pivoted, self-retaining, notched blades at the distal end. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LRC	Instrument, Ent Manual Surgical

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: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

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: 726b309f-9142-4ea1-a856-770e6c1c76f2
Public Version Date: March 24, 2023
Public Version Number: 1
DI Record Publish Date: March 16, 2023