AccessGUDID - DEVICE: ORLocate (05060356150229)

GUDID

Device Identifier (DI) Information

Brand Name: ORLocate
Version or Model: ORLocate Reader Box
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: OX203
Company Name: Steris Corporation

Primary DI Number: 05060356150229
Issuing Agency: GS1
Commercial Distribution End Date: March 13, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 177360039 *Terms of Use

Device Description: OrLocate Reader Box is used with the ORLocate Sponge Solution System.

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?
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
LWH	Counter, sponge, surgical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K100551	000

Device Exempt from Premarket Submission: No 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 2ca3d404-b457-4cda-a3bf-cc78e42c8ff4
Public Version Date: March 14, 2023
Public Version Number: 2
DI Record Publish Date: November 07, 2022