AccessGUDID - DEVICE: Straight guide Ø2 x 820 mm (07640187911343)

GUDID

Device Identifier (DI) Information

Brand Name: Straight guide Ø2 x 820 mm
Version or Model: T602
Commercial Distribution Status: In Commercial Distribution
Catalog Number: T602
Company Name: MPS Micro Precision Systems AG

Primary DI Number: 07640187911343
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 482204059 *Terms of Use

Device Description: The straight guide is used to lead intramedullary reamer in its proper course into the medullary canal. The end piece permits to prevent and retain the intramedullary reamer in case of sliding along the guide. The length varies from 440 to 820 mm and the diameter from 2 to 3 mm. Two kind of head, permitting to maintain the intramedullary reamer, exist. 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?
46165	Orthopaedic guidewire, reusable	A thin, non-implantable rod designed to guide the insertion of a cannulated/tubular orthopaedic implant (typically an intramedullary nail, a bone screw or femoral fixation plate) and/or surgical instrument (e.g., drill bit) during an orthopaedic procedure. It is made of metal and is available in a variety of sizes, lengths, and designs (e.g., round-tip, trocar-tip, or flexible-tip). This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FZX	Guide, Surgical, Instrument

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: 87bf49be-cbec-4efc-b511-286c63950bb4
Public Version Date: September 11, 2024
Public Version Number: 4
DI Record Publish Date: August 26, 2020