AccessGUDID - DEVICE: KIATO PLUS (08902895129151)

GUDID

Device Identifier (DI) Information

Brand Name: KIATO PLUS
Version or Model: 15
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 12915
Company Name: ADITYA DISPOMED PRODUCTS PRIVATE LIMITED

Primary DI Number: 08902895129151
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 675711147 *Terms of Use

Device Description: KIATO Plus Sterile Safety Scalpel Stainless Steel Box of 10 size 15. Sterilized using ethylene oxide.

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?
47569	Scalpel, single-use	A hand-held, manual surgical instrument constructed as a one-piece handle and scalpel blade (not an exchangeable component) used by the operator to manually cut or dissect tissue. The blade is typically made of high-grade stainless steel alloy or carbon steel and the handle is often made of plastic. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GDX	Scalpel, One-Piece

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: 3bbd861a-535b-49dc-b652-207a525024e4
Public Version Date: December 16, 2024
Public Version Number: 1
DI Record Publish Date: December 07, 2024