4701-136-010

GUDID 07613327278163

STRYKER CORPORATION

Birthing bed/table, powered

• Primary Device ID: 07613327278163
• NIH Device Record Key: e992e036-d101-494f-aaff-5bd7c168adb8
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 4701
• Catalog Number: 4701-136-010
• 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: 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

Operating and Storage Conditions

• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 500 KiloPascal and 1060 KiloPascal
• Handling Environment Atmospheric Pressure: Between 500 KiloPascal and 1060 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327278163 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K950889

FDA Product Code

• HDD: TABLE, OBSTETRICAL, AC-POWERED (AND ACCESSORIES)

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

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• 07613327163278 - NA: 2025-04-28
• 07613327601138 - OptaBlate: 2025-04-25 Curve 10mm Probe Single Kit
• 07613327601145 - OptaBlate: 2025-04-25 Curve 20mm Probe Single Kit
• 07613327601152 - OptaBlate: 2025-04-25 Curve 15mm Probe Single Kit
• 07613327631883 - OptaBlate: 2025-04-25 Straight 10MM Probe Dual Kit
• 07613327631890 - OptaBlate: 2025-04-25 Straight 10MM Probe Single Kit
• 07613327626391 - ThermaClear: 2025-04-14