AccessGUDID - DEVICE: Volition™ Plating System (05055662967791)

GUDID

Device Identifier (DI) Information

Brand Name: Volition™ Plating System
Version or Model: OS720023-NS
Commercial Distribution Status: In Commercial Distribution
Catalog Number: OS720023-NS
Company Name: ORTHO SOLUTIONS HOLDINGS LIMITED

Primary DI Number: 05055662967791
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 218648211 *Terms of Use

Device Description: VOLITION UNIVERSAL PLATE CADDY

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?
62851	Surgical instrument interim-placement holder, reusable	A device intended to be used in the operating room (OR) by staff to safely hold a manual, surgical instrument(s) [e.g., needle, scalpel, scissors] when not in use during surgery, to avoid damage to the instrument, and/or for temporary storage (e.g., to enable easy transfer/handling of the instrument at reduced risk of injury). It is available in various forms (e.g., rack, puncture cushion, telescopic tube, magnetic mat), and may be attached to a surgical drape; it is not a numbered tray and is not intended for counting of sharps. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OJH	Orthopedic Tray

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K210658	000

Device Exempt from Premarket Submission: No 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: 6000ed3c-e14c-4693-9152-127b2820ad69
Public Version Date: May 03, 2023
Public Version Number: 2
DI Record Publish Date: May 25, 2022