AccessGUDID - DEVICE: ORLocate (05060356150045)

GUDID

Device Identifier (DI) Information

Brand Name: ORLocate
Version or Model: ORLocate Drape
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: LC16961
Company Name: Steris Corporation

Primary DI Number: 05060356150045
Issuing Agency: GS1
Commercial Distribution End Date: May 05, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 177360039 *Terms of Use

Device Description: ORLocate Locator Drape with three straps, sterile is used with the ORLocate Sponge Solution System.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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):	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?
63219	Radio-frequency identification reader	An electronic device designed to read information stored on radio-frequency identification (RFID) tags within its read range, typically to identify and track medical devices. The reader may be of the passive (receives data only) or active (transmits and receives data) type, and may have the capability of storing and/or transmitting the read data.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PUI	Drape, surgical, exempt

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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

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: 4f06bdfd-286a-49c8-a02b-09778b1c874f
Public Version Date: May 08, 2023
Public Version Number: 2
DI Record Publish Date: September 30, 2022