eShield Cell Phone Size

GUDID M266EC21001

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	M266EC21001
NIH Device Record Key	7dd55f7f-7f44-4c2a-8d2b-ea03b06bceff
Commercial Distribution Status	In Commercial Distribution
Brand Name	eShield Cell Phone Size
Version Model Number	EC2100
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 Dimensions

Width	36 Centimeter
Depth	22 Centimeter
Width	23 Centimeter
Depth	11 Centimeter
Width	36 Centimeter
Depth	22 Centimeter
Width	23 Centimeter
Depth	11 Centimeter
Width	36 Centimeter
Depth	22 Centimeter
Width	23 Centimeter
Depth	11 Centimeter
Width	36 Centimeter
Depth	22 Centimeter
Width	23 Centimeter
Depth	11 Centimeter
Width	36 Centimeter
Depth	22 Centimeter
Width	23 Centimeter
Depth	11 Centimeter
Width	36 Centimeter
Depth	22 Centimeter
Width	23 Centimeter
Depth	11 Centimeter
Width	36 Centimeter
Depth	22 Centimeter
Width	23 Centimeter
Depth	11 Centimeter
Width	36 Centimeter
Depth	22 Centimeter
Width	23 Centimeter
Depth	11 Centimeter
Width	36 Centimeter
Depth	22 Centimeter
Width	23 Centimeter
Depth	11 Centimeter
Width	36 Centimeter
Depth	22 Centimeter
Width	23 Centimeter
Depth	11 Centimeter
Width	36 Centimeter
Depth	22 Centimeter
Width	23 Centimeter
Depth	11 Centimeter
Width	36 Centimeter
Depth	22 Centimeter
Width	23 Centimeter
Depth	11 Centimeter
Width	36 Centimeter
Depth	22 Centimeter
Width	23 Centimeter
Depth	11 Centimeter
Width	36 Centimeter
Depth	22 Centimeter
Width	23 Centimeter
Depth	11 Centimeter
Width	36 Centimeter
Depth	22 Centimeter
Width	23 Centimeter
Depth	11 Centimeter
Width	36 Centimeter
Depth	22 Centimeter
Width	23 Centimeter
Depth	11 Centimeter
Width	36 Centimeter
Depth	22 Centimeter
Width	23 Centimeter
Depth	11 Centimeter
Width	36 Centimeter
Depth	22 Centimeter
Width	23 Centimeter
Depth	11 Centimeter
Width	36 Centimeter
Depth	22 Centimeter
Width	23 Centimeter
Depth	11 Centimeter
Width	36 Centimeter
Depth	22 Centimeter
Width	23 Centimeter
Depth	11 Centimeter
Width	36 Centimeter
Depth	22 Centimeter
Width	23 Centimeter
Depth	11 Centimeter
Width	36 Centimeter
Depth	22 Centimeter
Width	23 Centimeter
Depth	11 Centimeter
Width	36 Centimeter
Depth	22 Centimeter
Width	23 Centimeter
Depth	11 Centimeter
Width	36 Centimeter
Depth	22 Centimeter
Width	23 Centimeter
Depth	11 Centimeter
Width	36 Centimeter
Depth	22 Centimeter
Width	23 Centimeter
Depth	11 Centimeter
Width	36 Centimeter
Depth	22 Centimeter
Width	23 Centimeter
Depth	11 Centimeter
Width	36 Centimeter
Depth	22 Centimeter
Width	23 Centimeter
Depth	11 Centimeter
Width	36 Centimeter
Depth	22 Centimeter
Width	23 Centimeter
Depth	11 Centimeter
Width	36 Centimeter
Depth	22 Centimeter
Width	23 Centimeter
Depth	11 Centimeter
Width	36 Centimeter
Depth	22 Centimeter
Width	23 Centimeter
Depth	11 Centimeter
Width	36 Centimeter
Depth	22 Centimeter
Width	23 Centimeter
Depth	11 Centimeter
Width	36 Centimeter
Depth	22 Centimeter
Width	23 Centimeter
Depth	11 Centimeter
Width	36 Centimeter
Depth	22 Centimeter
Width	23 Centimeter
Depth	11 Centimeter
Width	36 Centimeter
Depth	22 Centimeter
Width	23 Centimeter
Depth	11 Centimeter
Width	36 Centimeter
Depth	22 Centimeter
Width	23 Centimeter
Depth	11 Centimeter
Width	36 Centimeter
Depth	22 Centimeter
Width	23 Centimeter
Depth	11 Centimeter
Width	36 Centimeter
Depth	22 Centimeter
Width	23 Centimeter
Depth	11 Centimeter
Width	36 Centimeter
Depth	22 Centimeter
Width	23 Centimeter
Depth	11 Centimeter
Width	36 Centimeter
Depth	22 Centimeter
Width	23 Centimeter
Depth	11 Centimeter
Width	36 Centimeter
Depth	22 Centimeter
Width	23 Centimeter
Depth	11 Centimeter
Width	36 Centimeter
Depth	22 Centimeter
Width	23 Centimeter
Depth	11 Centimeter
Width	36 Centimeter
Depth	22 Centimeter
Width	23 Centimeter
Depth	11 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M266EC21000 [Primary]
HIBCC	M266EC21001 [Package] Contains: M266EC21000 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

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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	2021-02-05The 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.
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	2021-02-05 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