SURGICOUNT 0631-008-108
GUDID 57613327513207
+ SAFE-T-Lap Sponge, 8 inch x 108 inch, RFID, X-Ray
STRYKER CORPORATION
Radiopaque woven surgical sponge, non-sterile| Primary Device ID | 57613327513207 |
| NIH Device Record Key | cf2cf22c-b4a4-4205-874a-819900c46dd5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SURGICOUNT |
| Version Model Number | 0631008108 |
| Catalog Number | 0631-008-108 |
| Company DUNS | 196548481 |
| Company Name | STRYKER CORPORATION |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | MR Safe |
| 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Operating and Storage Conditions
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07613327513202 [Primary] |
| GS1 | 37613327513203 [Package] Contains: 07613327513202 Package: pack [1 Units] In Commercial Distribution |
| GS1 | 57613327513207 [Package] Contains: 37613327513203 Package: case [40 Units] In Commercial Distribution |
FDA Product Code
| GDY | GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-07-05 |
| Device Publish Date | 2021-06-25 |
On-Brand Devices [SURGICOUNT]
| 07613327298345 | SurgiCount? Tablet Pole Mount |
| 07613327298338 | SurgiCount? Tablet Dock |
| 07613327298321 | SurgiCount? Tablet Wall Mount |
| 07613327298314 | SurgiCount? Power Supply |
| 07613327298307 | SurgiCount? Tablet Battery |
| 07613327298291 | SurgiCount? Dock Wall Mount |
| 07613327298284 | SurgiCount? Tablet |
| 07613327545364 | APPLICATION |
| 07613327513301 | + CRADLE POLE MOUNT |
| 07613327513295 | + CRADLE |
| 57613327512682 | + Gauze Sponge, 4 inch x 4 inch, 16 Ply, RFID, Double Wavy X-Ray |
| 57613327513207 | + SAFE-T-Lap Sponge, 8 inch x 108 inch, RFID, X-Ray |
| 07613327513189 | + SAFE-T-Lap Sponge, 8 inch x 36 inch, RFID, X-Ray |
| 07613327513127 | + OR Towel, Blue, RFID, X-Ray, 5/Pack |
| 07613327513097 | + OR Towel, Green, RFID, X-Ray, 2/Pack |
| 07613327513073 | + OR Towel, Blue, RFID, X-Ray, 2/Pack |
| 07613327512762 | + SAFE-T-Lap Sponge, 18 inch x 18 inch, RFID, X-Ray, No Loop |
| 07613327512755 | + SAFE-T-Lap Sponge, 18 inch x 36 inch, RFID, X-Ray |
| 07613327512748 | + SAFE-T-Lap Sponge, 18 inch x 18 inch, RFID, X-Ray, Plastic Ring |
| 07613327512731 | + SAFE-T-Lap Sponge, 12 inch x 12 inch, RFID, X-Ray |
| 07613327512724 | + SAFE-T-Lap Sponge, 8 inch x 36 inch, RFID, X-Ray, Plastic Ring |
| 07613327512717 | + SAFE-T-Lap Sponge, 18 inch x 18 inch, RFID, X-Ray |
| 07613327512700 | + SAFE-T-Lap Sponge, 4 inch x 18 inch, RFID, X-Ray |
| 37613327512565 | + Gauze Sponge, 8 inch x 4 inch, 24 Ply, RFID, Double X-Ray |
| 07613327512557 | + Gauze Sponge, 8 inch x 4 inch, 16 Ply, RFID, Double X-Ray |
| 07613327512540 | + Gauze Sponge, 4 inch x 4 inch, 32 Ply, RFID, Double X-Ray |
| 07613327512533 | + Gauze Sponge, 8 inch x 4 inch, 12 Ply, RFID, Double X-Ray |
| 07613327512526 | + Gauze Sponge, 4 inch x 4 inch, 16 Ply, RFID, Double X-Ray |
| 57613327519506 | + SPONGE COUNTING BAG |
| 57613327517977 | + READER COVER |
| 57613327513177 | + Gauze Sponge, 8 inch x 4 inch, 12 Ply, RFID, Double X-Ray |
| 57613327512866 | + OR Towel, Blue, RFID, X-Ray, 2/Pack |
| 57613327512842 | + SAFE-T-Lap Sponge, 18 inch x 36 inch, RFID, X-Ray |
| 57613327512835 | + SAFE-T-Lap Sponge, 18 inch x 18 inch, RFID, X-Ray, No Loop |
| 57613327512828 | + SAFE-T-Lap Sponge, 8 inch x 36 inch, RFID, X-Ray, Plastic Ring |
| 57613327512811 | + SAFE-T-Lap Sponge, 18 inch x 18 inch, RFID, X-Ray, Plastic Ring |
| 57613327512804 | + SAFE-T-Lap Sponge, 18 inch x 18 inch, RFID, X-Ray |
| 57613327512798 | + SAFE-T-Lap Sponge, 8 inch x 36 inch, RFID, X-Ray |
| 57613327512781 | + SAFE-T-Lap Sponge, 12 inch x 12 inch, RFID, X-Ray |
| 57613327512774 | + SAFE-T-Lap Sponge, 4 inch x 18 inch, RFID, X-Ray |
| 57613327512699 | + Gauze Sponge, 8 inch x 4 inch, 24 Ply, RFID, Double X-Ray |
| 57613327512675 | + Gauze Sponge, 8 inch x 4 inch, 16 Ply, RFID, Double X-Ray |
| 57613327512668 | + Gauze Sponge, 4 inch x 4 inch, 32 Ply, RFID, Double X-Ray |
| 57613327512644 | + Gauze Sponge, 4 inch x 4 inch, 16 Ply, RFID, Double X-Ray |
| 07613327543094 | + APPLICATION |
| 07613327519525 | + STAND |
| 07613327519518 | + CRADLE WALL MOUNT |
| 07613327515855 | + READER |
| 07613327513141 | + OR Towel, White, RFID, X-Ray, 5/Pack |
| 07613327513134 | + OR Towel, Green, RFID, X-Ray, 5/Pack |
Trademark Results [SURGICOUNT]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SURGICOUNT 78871542 3703648 Live/Registered |
STRYKER CORPORATION 2006-04-27 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.