AccessGUDID - DEVICE: OSSEOUS Myringotomy knife (08906039319668)

GUDID

Device Identifier (DI) Information

Brand Name: OSSEOUS Myringotomy knife
Version or Model: EI0966
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: EON MEDITECH PRIVATE LIMITED

Primary DI Number: 08906039319668
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 930270428 *Terms of Use

Device Description: Myringotomy Knife is used to make an incision in the tympanic membrane (ear drum) into which a “Grommet” can be placed. The handle design aids orientation for accuracy and confidence when making incisions. The consistently sharp, angled blade facilitates a clean cut.

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?
38103	Nasal knife	A hand-held manual surgical instrument designed to cut and dissect internal nasal tissue, including the nasal septum, during ear/nose/throat (ENT) surgery. It is typically a one-piece instrument made of high-grade stainless steel with a long, slender shaft with a handle at the proximal end and a sharp, single-edged, cutting blade at the distal end. The blade is normally small and typically of various forms (e.g., sharply-pointed, double-edged, with swivel devices) according to the procedure to be performed (e.g., submucous dissection, septal surgery). This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JYG	Curette, Ear

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
Storage Environment Temperature: less than 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Length: 5.38 Millimeter
Length: 172 Millimeter

Device Record Status

Public Device Record Key: d3c74f86-54ec-47cc-a062-c6a4dccf38be
Public Version Date: July 12, 2024
Public Version Number: 1
DI Record Publish Date: July 04, 2024