ORLocate OX100
GUDID 00724995220624
ORLocate Sponge Solution is an innovative counting and locating technology that enhances patient safety and reduces time spent counting and searching for sponges in the operating room.
Steris Corporation
Radio-frequency identification reader| Primary Device ID | 00724995220624 |
| NIH Device Record Key | 1b4ba7ca-e0fe-4e5c-b154-f8dd1b949b4c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ORLocate |
| Version Model Number | ORLocate Sponge Solution |
| Catalog Number | OX100 |
| 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 |
| xx@xx.xx | |
| Phone | +1(800)548-4873 |
| xx@xx.xx | |
| Phone | +1(800)548-4873 |
| xx@xx.xx | |
| Phone | +1(800)548-4873 |
| xx@xx.xx |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00724995220624 [Primary] |
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 | 2022-12-15 |
| Device Publish Date | 2022-12-07 |
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 |
Trademark Results [ORLocate]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ORLOCATE 85362637 4313783 Live/Registered |
Haldor Advanced Technologies Ltd. 2011-07-04 |
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