AccessGUDID - DEVICE: Subtilis Chisel Lexer straight long blade plastic handle with impact plate 10 mm (07640229290047)

GUDID

Device Identifier (DI) Information

Brand Name: Subtilis Chisel Lexer straight long blade plastic handle with impact plate 10 mm
Version or Model: 35.12.10
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Accuratus AG

Primary DI Number: 07640229290047
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 483290367 *Terms of Use

Device Description: Subtilis Chisel Lexer straight long blade plastic handle with impact plate 10 mm 23 cm

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:	No
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?
10825	Orthopaedic chisel	A hand-held, single-blade surgical instrument, bevelled on one side, designed to cut and shape bone during orthopaedic surgery. It is hand-held by the operator who uses a surgical mallet or hammer to manually impart a force to the proximal end of the instrument. The distal end (the cutting or shaping edge) is sharp, flat or curved [(concave) - also known as a hollow blade] in design. It is either entirely made of metal (e.g., high-grade stainless steel) or has a metal blade with a handle made of synthetic material (e.g., Tufnol). This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FZO	Chisel, Surgical, Manual

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 [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a056f473-8962-4214-9715-2ccce9e81164
Public Version Date: August 07, 2020
Public Version Number: 1
DI Record Publish Date: July 30, 2020