Primary Device ID | 30724995220786 |
NIH Device Record Key | b5ecd95a-1eed-417b-945c-6f0599e0aa0a |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | ORLocate |
Version Model Number | ORLocate Gauze |
Catalog Number | GTS0404X810NS |
Company DUNS | 177360039 |
Company Name | Steris Corporation |
Device Count | 10 |
DM Exempt | false |
Pre-market Exempt | true |
MRI Safety Status | MR Unsafe |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | true |
RX Perscription | true |
OTC Over-The-Counter | false |
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 |
Width | 4 Inch |
Length | 4 Inch |
Width | 4 Inch |
Length | 4 Inch |
Width | 4 Inch |
Length | 4 Inch |
Width | 4 Inch |
Length | 4 Inch |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00724995220785 [Unit of Use] |
GS1 | 10724995220782 [Primary] |
GS1 | 30724995220786 [Package] Contains: 10724995220782 Package: Carton [14 Units] In Commercial Distribution |
GS1 | 50724995220780 [Package] Package: Case [20 Units] In Commercial Distribution |
NAB | Gauze / sponge,nonresorbable for external use |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2022-12-15 |
Device Publish Date | 2022-12-07 |
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 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ORLOCATE 85362637 4313783 Live/Registered |
Haldor Advanced Technologies Ltd. 2011-07-04 |