AccessGUDID - DEVICE: Chisel handle (07640187910513)

GUDID

Device Identifier (DI) Information

Brand Name: Chisel handle
Version or Model: T14584
Commercial Distribution Status: In Commercial Distribution
Catalog Number: T14584
Company Name: MPS Micro Precision Systems AG

Primary DI Number: 07640187910513
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 482204059 *Terms of Use

Device Description: A hand-held instrument used to maintain and hold chisel blade of different designs (straight, curved, offset, etc.). The exchange of the chisel blades occur simply by tightening and loosening the screw by use of the Allen key. In case the chisel blade remains stocked, the slap hammer can be screwed at the handle extremity. This is a reusable device.

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):	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?
62895	Orthopaedic osteotome handle	A hand-held component of an orthopaedic osteotome intended to be attached to an interchangeable blade (not included) to become a chisel-like surgical instrument designed to cut and/or shape bone by percussion during an orthopaedic procedure. The operator holds this part of the instrument and manually imparts a force to it using a surgical mallet or hammer; it is made of metal and/or polymer materials. 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: 045c9c38-2299-425d-9c35-b94b833d79b1
Public Version Date: November 18, 2022
Public Version Number: 2
DI Record Publish Date: August 25, 2020