eShield Digital Camera Size

GUDID M266EC22001

The Whitney Medical Solutions’ eShield consists of polyethylene film (and an adhesive pad in some models) with tear guide tape and a zipper that allows the cover to be torn fairly straight across it. There is also a double sided tape below the zipper that is used as a redundant closure method with the cover being folded twice and sealed against it. The device is provided to the user sterile, is labeled for single use only and not intended for resterilization or reprocessing. The sterile eShield is sterilized using a validated irradiation sterilization method.

Whitney Medical Solutions

Patient surgical drape, single-use

• Primary Device ID: M266EC22001
• NIH Device Record Key: f34ff369-8e32-4b06-b65d-6c51a8fcca7e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: eShield Digital Camera Size
• Version Model Number: EC2200
• Company DUNS: 119676187
• Company Name: Whitney Medical Solutions
• 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: true
• Lot Batch: true
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M266EC22000 [Primary]
HIBCC	M266EC22001 [Package]; Contains: M266EC22000; Package: [25 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141438

FDA Product Code

• KKX: Drape, Surgical

Sterilization

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

[M266EC22001]

Radiation Sterilization

[M266EC22001]

Radiation Sterilization

[M266EC22001]

Radiation Sterilization

[M266EC22001]

Radiation Sterilization

[M266EC22001]

Radiation Sterilization

[M266EC22001]

Radiation Sterilization

[M266EC22001]

Radiation Sterilization

[M266EC22001]

Radiation Sterilization

[M266EC22001]

Radiation Sterilization

[M266EC22001]

Radiation Sterilization

[M266EC22001]

Radiation Sterilization

[M266EC22001]

Radiation Sterilization

[M266EC22001]

Radiation Sterilization

[M266EC22001]

Radiation Sterilization

[M266EC22001]

Radiation Sterilization

[M266EC22001]

Radiation Sterilization

[M266EC22001]

Radiation Sterilization

[M266EC22001]

Radiation Sterilization

[M266EC22001]

Radiation Sterilization

[M266EC22001]

Radiation Sterilization

[M266EC22001]

Radiation Sterilization

[M266EC22001]

Radiation Sterilization

[M266EC22001]

Radiation Sterilization

[M266EC22001]

Radiation Sterilization

[M266EC22001]

Radiation Sterilization

[M266EC22001]

Radiation Sterilization

[M266EC22001]

Radiation Sterilization

[M266EC22001]

Radiation Sterilization

[M266EC22001]

Radiation Sterilization

[M266EC22001]

Radiation Sterilization

[M266EC22001]

Radiation Sterilization

[M266EC22001]

Radiation Sterilization

[M266EC22001]

Radiation Sterilization

[M266EC22001]

Radiation Sterilization

[M266EC22001]

Radiation Sterilization

[M266EC22001]

Radiation Sterilization

[M266EC22001]

Radiation Sterilization

[M266EC22001]

Radiation Sterilization

[M266EC22001]

Radiation Sterilization

[M266EC22001]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2021-02-05
• Device Publish Date: 2016-09-20

Devices Manufactured by Whitney Medical Solutions

• M266EC21001 - eShield Cell Phone Size: 2021-02-05 The Whitney Medical Solutions’ eShield consists of polyethylene film (and an adhesive pad in some models) with tear guide tape
• M266EC22001 - eShield Digital Camera Size: 2021-02-05The Whitney Medical Solutions’ eShield consists of polyethylene film (and an adhesive pad in some models) with tear guide tape and a zipper that allows the cover to be torn fairly straight across it. There is also a double sided tape below the zipper that is used as a redundant closure method with the cover being folded twice and sealed against it. The device is provided to the user sterile, is labeled for single use only and not intended for resterilization or reprocessing. The sterile eShield is sterilized using a validated irradiation sterilization method.
• M266EC22001 - eShield Digital Camera Size: 2021-02-05 The Whitney Medical Solutions’ eShield consists of polyethylene film (and an adhesive pad in some models) with tear guide tape
• M266EC23001 - eShield Tablet Size: 2021-02-05 The Whitney Medical Solutions’ eShield consists of polyethylene film (and an adhesive pad in some models) with tear guide tape
• M266EC24001 - eShield SLR Camera Size: 2021-02-05 The Whitney Medical Solutions’ eShield consists of polyethylene film (and an adhesive pad in some models) with tear guide tape