LEWIN

GUDID 06976041611106

Shandong Lewin Medical Equipment Co., Ltd.

Operating room light

• Primary Device ID: 06976041611106
• NIH Device Record Key: cfd792a2-5cb3-4ae1-a9d7-17f3116e82b0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LEWIN
• Version Model Number: CreLed 5500M
• Company DUNS: 546175601
• Company Name: Shandong Lewin Medical Equipment Co., Ltd.
• Device Count: 1
• DM Exempt: true
• 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: true
• Expiration Date: true
• 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	06976041611106 [Primary]

FDA Product Code

• FSY: Light, Surgical, Ceiling Mounted

Sterilization

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

[06976041611106]

Dry Heat Sterilization

[06976041611106]

Dry Heat Sterilization

[06976041611106]

Dry Heat Sterilization

[06976041611106]

Dry Heat Sterilization

[06976041611106]

Dry Heat Sterilization

[06976041611106]

Dry Heat Sterilization

[06976041611106]

Dry Heat Sterilization

[06976041611106]

Dry Heat Sterilization

[06976041611106]

Dry Heat Sterilization

[06976041611106]

Dry Heat Sterilization

[06976041611106]

Dry Heat Sterilization

[06976041611106]

Dry Heat Sterilization

[06976041611106]

Dry Heat Sterilization

[06976041611106]

Dry Heat Sterilization

[06976041611106]

Dry Heat Sterilization

[06976041611106]

Dry Heat Sterilization

[06976041611106]

Dry Heat Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-02-17
• Device Publish Date: 2023-02-09

On-Brand Devices [LEWIN]

• 06976041611069: CreLed 3300
• 06976041613049: CreLife 6000
• 06976041613032: CreLife 3000
• 06976041613025: CreLife 2000
• 06976041613018: CreLife 100
• 06976041612066: CreBle 2100
• 06976041612059: CreBle 1500
• 06976041612042: CreBle 200
• 06976041612035: CreBle 3000
• 06976041612028: CreBle 2000
• 06976041612011: CreBle 1000
• 06976041611144: CreLed 150M
• 06976041611137: CreLed 310M
• 06976041611120: Hollow CreLed 5500M
• 06976041611113: CreLed 3300M
• 06976041611106: CreLed 5500M
• 06976041611090: Hollow CreLed 5500
• 06976041611083: Hollow CreLed 5700
• 06976041611076: Hollow CreLed 5700/5500
• 06976041611052: CreLed 3400
• 06976041611045: CreLed 3400/3300
• 06976041611038: CreLed 5500
• 06976041611021: CreLed 5700
• 06976041611014: CreLed 5700/5500