AccessGUDID - DEVICE: OSSEOUS Stapes Prosthesis Crimping Forceps (08906039316032)

GUDID

Device Identifier (DI) Information

Brand Name: OSSEOUS Stapes Prosthesis Crimping Forceps
Version or Model: EI04
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: EON MEDITECH PRIVATE LIMITED

Primary DI Number: 08906039316032
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 930270428 *Terms of Use

Device Description: It is used to crimping of stapes piston loop after proper placement of stapes piston on long process of incus.

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?
11791	Dressing/utility forceps, scissors-like, reusable	A hand-held manual instrument designed primarily for non-dedicated grasping of devices, sponges and/or dressings during a procedure; it is neither intended for tissue manipulation nor endoscopic use. It has a scissors-like hinged design with ring handles and blades (non-cutting) that may be available in a range of sizes or designs. It may be intended for use at a specific anatomy. This is a reusable device intended to be sterilized prior to use.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KAE	Forceps, 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: 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
No Device Sizes

Device Record Status

Public Device Record Key: 956e1e66-e534-45cf-9999-9a5c1ab2e9f6
Public Version Date: July 12, 2024
Public Version Number: 1
DI Record Publish Date: July 04, 2024