AccessGUDID - DEVICE: LARYNGEAL MIRROR (B974LYM30)

GUDID

Device Identifier (DI) Information

Brand Name: LARYNGEAL MIRROR
Version or Model: LARYNGEAL MIRROR
Commercial Distribution Status: In Commercial Distribution
Catalog Number: LYM3
Company Name: DR.FRIGZ INTERNATIONAL(PVT)LTD,

Primary DI Number: B974LYM30
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 645680125 *Terms of Use

Device Description: LARYNGEAL MIRROR NO-3, 8" FINISH

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?
63841	Laryngeal mirror, single-use	A hand-held manual surgical instrument with a mirror or a surface sufficiently polished to reflect enough undiffused light to form a virtual image of an object placed before it at the distal end, intended to be used for a laryngeal examination. The mirror is affixed at an angle to a long, slender shaft with a handle at the proximal end that is held by the doctor who can manipulate the mirror close to the site of interest in the throat. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KAI	Mirror, Ent

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 [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 8 Inch

Device Record Status

Public Device Record Key: 6b28ae4d-3d29-4488-8e66-a682fcff3493
Public Version Date: November 29, 2022
Public Version Number: 1
DI Record Publish Date: November 21, 2022