AccessGUDID - DEVICE: Devon (10884527019045)

GUDID

Device Identifier (DI) Information

Brand Name: Devon
Version or Model: 31159570
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 31159570
Company Name: Cardinal Health, Inc.

Primary DI Number: 10884527019045
Issuing Agency: GS1
Commercial Distribution End Date: July 01, 2023
Device Count: 130
Labeler D-U-N-S® Number*: 080935429 *Terms of Use

Device Description: Magnetic Drape

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):	Yes
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
61665	Surgical instrument containment holder, single-use, non-sterile	A non-sterile device intended to be used in the operating room (OR) by staff to safely contain/support a delicate or sharp hand-held, manual, surgical instrument(s) [e.g., needle, scalpel, scissors] to avoid damage to the instrument during surgery and/or to enable easy transfer/handling of the instrument at reduced risk of injury. It is available in various forms (e.g., rack, rest, puncture cushion, pocket, 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 single-use device intended to be sterilized prior to use.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
FZZ	Marker, Skin

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: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: ;

Clinically Relevant Size

[?]

Size Type Text
Width: 10 Inch
Length: 16 Inch

Device Record Status

Public Device Record Key: e0a16908-323d-4cef-a3e2-f6ad2a7c9f66
Public Version Date: July 03, 2023
Public Version Number: 9
DI Record Publish Date: September 24, 2016