AccessGUDID - DEVICE: KIATO PLUS (08902895182156)

GUDID

Device Identifier (DI) Information

Brand Name: KIATO PLUS
Version or Model: 15
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 18215
Company Name: ADITYA DISPOMED PRODUCTS PRIVATE LIMITED

Primary DI Number: 08902895182156
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 675711147 *Terms of Use

Device Description: KIATO PLUS Sterile Carbon Steel Rib Back Surgical Blade Box of 100 size 15. Sterilized by Gamma irradiation.

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):	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?
37445	Manual scalpel blade, single-use	An interchangeable device designed to mount a compatible handle and function as the cutting edge of a scalpel. It is made of high-grade stainless steel alloy and is used as a surgical instrument to cut and dissect tissues. Safety mechanisms (e.g., a retractable protective guard made of plastic) may be included. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GES	Blade, Scalpel

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: between 5 and 45 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 53f89214-88a0-4da7-86ab-e8150c2e3c01
Public Version Date: December 16, 2024
Public Version Number: 1
DI Record Publish Date: December 06, 2024