SURGICOUNT 0794001090

GUDID 07613327545364

APPLICATION

STRYKER CORPORATION

Electronic surgical sponge-counter

• Primary Device ID: 07613327545364
• NIH Device Record Key: b1f11ad0-44db-4c6b-89bb-3854d5ec554d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SURGICOUNT
• Version Model Number: 0794001090
• Catalog Number: 0794001090
• Company DUNS: 196548481
• Company Name: STRYKER CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• Manufacturing Date: false
• Expiration Date: false
• 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

• Phone: +1(800)253-3210
• Email: Inst.Stryker.cs@Stryker.com
• Phone: +1(800)253-3210
• Email: Inst.Stryker.cs@Stryker.com
• Phone: +1(800)253-3210
• Email: Inst.Stryker.cs@Stryker.com
• Phone: +1(800)253-3210
• Email: Inst.Stryker.cs@Stryker.com
• Phone: +1(800)253-3210
• Email: Inst.Stryker.cs@Stryker.com
• Phone: +1(800)253-3210
• Email: Inst.Stryker.cs@Stryker.com
• Phone: +1(800)253-3210
• Email: Inst.Stryker.cs@Stryker.com
• Phone: +1(800)253-3210
• Email: Inst.Stryker.cs@Stryker.com
• Phone: +1(800)253-3210
• Email: Inst.Stryker.cs@Stryker.com
• Phone: +1(800)253-3210
• Email: Inst.Stryker.cs@Stryker.com
• Phone: +1(800)253-3210
• Email: Inst.Stryker.cs@Stryker.com
• Phone: +1(800)253-3210
• Email: Inst.Stryker.cs@Stryker.com
• Phone: +1(800)253-3210
• Email: Inst.Stryker.cs@Stryker.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327545364 [Primary]

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: 2021-04-20
• Device Publish Date: 2021-04-12

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