ORLocate OX203

GUDID 00724995220662

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

Steris Corporation

Radio-frequency identification reader Radio-frequency identification reader Radio-frequency identification reader Radio-frequency identification reader Radio-frequency identification reader Radio-frequency identification reader Radio-frequency identification reader Radio-frequency identification reader Radio-frequency identification reader Radio-frequency identification reader Radio-frequency identification reader Radio-frequency identification reader Radio-frequency identification reader Radio-frequency identification reader Radio-frequency identification reader Radio-frequency identification reader Radio-frequency identification reader

• Primary Device ID: 00724995220662
• NIH Device Record Key: a7e2c5ca-48a7-430b-b257-babb24d16758
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ORLocate
• Version Model Number: ORLocate Reader Box
• Catalog Number: OX203
• Company DUNS: 177360039
• Company Name: Steris Corporation
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	00724995220662 [Primary]
GS1	05060356150229 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100551

FDA Product Code

• LWH: Counter, sponge, surgical

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-03-22
• Device Publish Date: 2023-03-14

On-Brand Devices [ORLocate]

• 55060356150057: ORLocate Locator Drape with three straps, non-sterile is used with the ORLocate Sponge Solution
• 55060356150033: ORLocate HoveRead Drape with two straps, non-sterile is used with the ORLocate Sponge Solution S
• 55060356150019: ORLocate Locator Drape with two straps, non-sterile is used with the ORLocate Sponge Solution Sy
• 55060356150040: ORLocate Locator Drape with three straps, sterile is used with the ORLocate Sponge Solution Syst
• 55060356150026: ORLocate HoveRead Drape with two straps, sterile is used with the ORLocate Sponge Solution Syst
• 55060356150002: ORLocate Locator Drape with two straps, sterile is used with the ORLocate Sponge Solution System
• 35060356150411: ORLocate RFID Gauze Lap Sponge is used with the ORLocate Sponge Solution System.
• 55060356150408: ORLocate RFID Gauze 16-ply is used with the ORLocate Sponge Solution System.
• 55060356150156: ORLocate RFID Vaginal Packing Loop and Fold is used with the ORLocate Sponge Solution System.
• 35060356150145: ORLocate RFID Gauze Lap Sponge is used with the ORLocate Sponge Solution System.
• 55060356150071: ORLocate RFID Gauze Lap Sponge is used with the ORLocate Sponge Solution System.
• 05060356150229: OrLocate Reader Box is used with the ORLocate Sponge Solution System.
• 05060356150212: OrLocate HoveRead is a used with the ORLocate Sponge Solution System.
• 05060356150205: OrLocate Locator is a component to the ORLocate Sponge Solution System.
• 50724995221107: ORLocate RFID Tonsil Sponge, Tape Strung, X-Ray, 0.875 inch diameter, Sterile is used with the O
• 50724995221084: ORLocate RFID Tonsil Sponge, Tape Strung, X-Ray, 1-inch diameter, Sterile is used with the ORLoc
• 50724995221077: ORLocate RFID Tonsil Sponge, Tape Strung, X-Ray, 1.25 inch diameter, Sterile is used with the OR
• 50724995221060: ORLocate RFID Tonsil Sponge, Tape Strung, X-Ray, 1.5 inch diameter, Sterile is used with the ORL
• 50724995221053: ORLocate RFID Tonsil Sponge, Double Strung, X-Ray, 0.875 inch diameter, Sterile is used with the
• 50724995221046: ORLocate RFID Tonsil Sponge, Double Strung, X-Ray, 0.75 inch diameter, Sterile is used with the
• 50724995221039: ORLocate RFID Tonsil Sponge, Double Strung, X-Ray, 1-inch diameter, Sterile is used with the ORL
• 50724995221015: ORLocate RFID Tonsil Sponge, Double Strung, X-Ray, 1.5 inch diameter, Sterile is used with the O
• 30724995221004: ORLocate RFID Vaginal Packing, 4-inchx18-inch, Loop, Folded, X-ray, Non-sterile is used with the
• 50724995220995: ORLocate RFID Vaginal Packing; 4-inch x 18-inch, Loop, Folded, X-ray, Sterile is used with the O
• 50724995220988: ORLocate RFID Vaginal Packing, 2-inch x 72-inch, Loop, Folded, X-ray, Non-sterile is used with
• 30724995220960: ORLocate RFID OR Towel, Green, X-ray, Non-sterile is used with the ORLocate Sponge Solution Syst
• 50724995220957: ORLocate RFID OR Towel, Green, X-ray, Sterile is used with the ORLocate Sponge Solution System.
• 30724995220946: ORLocate RFID OR Towel, Blue, X-ray, Non-sterile is used with the ORLocate Sponge Solution Syste
• 50724995220933: ORLocate RFID OR Towel, Blue, X-ray, Sterile is used with the ORLocate Sponge Solution System.
• 50724995220926: ORLocate RFID Lap Sponge, 18-inch x 36-inch, X-ray, Non-sterile is used with the ORLocate Sponge
• 50724995220919: ORLocate RFID Lap Sponge, 18-inch x 36-inch, X-ray, Sterile is used with the ORLocate Sponge Sol
• 50724995220902: ORLocate RFID Lap Sponge, 18-inch x 18-inch, X-ray, Unwashed, Non-sterile is used with the ORLoc
• 50724995220896: ORLocate RFID Lap Sponge, 18-inch x 18-inch, X-ray, Unwashed, Sterile is used with the ORLocate
• 30724995220885: ORLocate RFID Lap Sponge, 18-inch x 18-inch, X-ray, No Loop, Non-sterile is used with the ORLoca
• 30724995220861: ORLocate RFID Lap Sponge, 18-inch x 18-inch, X-ray, Non-sterile is used with the ORLocate Sponge
• 50724995220858: ORLocate RFID Lap Sponge, 18-inch x 18-inch, X-ray, Sterile is used with the ORLocate Sponge Sol
• 50724995220841: ORLocate RFID Lap Sponge, 17-inch x 26-inch, X-ray, Non-sterile is used with the ORLocate Sponge
• 50724995220834: ORLocate RFID Lap Sponge, 17-inch x 26-inch, X-ray, Sterile is used with the ORLocate Sponge Sol
• 50724995220810: ORLocate RFID Lap Sponge, 4-inch x 9-inch, X-ray, Sterile is used with the ORLocate Sponge Solut
• 30724995220809: ORLocate RFID Gauze, 8-inch x 4-inch, 32-ply, X-ray, Non-sterile is used with the ORLocate Spong
• 50724995220797: ORLocate RFID Gauze, 8-inch x 4-inch, 32-ply, X-ray, Sterile is used with the ORLocate Sponge So
• 30724995220786: ORLocate RFID Gauze 4-inch x 4-inch, 8-ply, X-ray; Non-sterile is used with the ORLocate Sponge
• 50724995220773: ORLocate RFID Gauze, 4-inch x 4-inch, 8-ply, X-ray, Sterile is used with the ORLocate Sponge Sol
• 50724995220766: ORLocate RFID Gauze, 4-inch x 4-inch, 12-ply, X-ray, Sterile is used with the ORLocate Sponge So
• 50724995220728: ORLocate RFID Gauze, 2-inch x 2-inch, 8-ply, X-ray, Sterile is used with the ORLocate Sponge Sol
• 50724995220711: ORLocate RFID Gauze, 2-inch x 2-inch;, 12-ply, X-ray, Non-sterile is used with the ORLocate Spon
• 50724995220704: ORLocate RFID Gauze, 2-inch x 2-inch, 12-ply, X-ray, Sterile is used with the ORLocate Sponge So
• 30724995220540: ORLocate RFID OR Towel, White, X-Ray, Non-sterile is used with the ORLocate Sponge Solution Syst
• 50724995220537: ORLocate RFID Lap Sponge, 18-inch x 18-inch, X-Ray, Ring, Sterile is used with the ORLocate Spon
• 30724995220519: ORLocate RFID Lap Sponge, 12-inch x 12-inch, X-Ray, Non-sterile is used with the ORLocate Sponge