DP400CE

GUDID 57613327169329

STRYKER CORPORATION

General-purpose patient temperature probe, single-use

• Primary Device ID: 57613327169329
• NIH Device Record Key: f6cc82b5-1249-4977-ac7b-2f1d4bc74358
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: DP400CE
• Catalog Number: DP400CE
• Company DUNS: 078470558
• Company Name: STRYKER 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: true
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327169324 [Primary]
GS1	57613327169329 [Package]; Contains: 07613327169324; Package: case [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100585

FDA Product Code

• DWJ: System, thermal regulating

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

Devices Manufactured by STRYKER CORPORATION

• 07613327625134 - Steri-Shield: 2025-03-06 8 SURGICAL HELMET
• 07613327625202 - Steri-Shield: 2025-03-06 8 BATTERY
• 07613327627039 - STERI-SHIELD: 2025-03-06 8 SURGICAL HELMET WITH LIGHT
• 07613327652154 - ProCuity: 2025-03-04 ProCuity L + IsoFlex
• 07613327652161 - ProCuity: 2025-03-04 ProCuity LE + IsoFlex
• 07613327652178 - ProCuity: 2025-03-04 ProCuity LE + ComfortGel
• 07613327652192 - ProCuity: 2025-03-04 ProCuity LEX + ComfortGel
• 07613327652215 - ProCuity: 2025-03-04 ProCuity LEX + IsoFlex