eShield Cell Phone Size

Basic Information

• Brand Name: eShield Cell Phone Size
• Primary DI: M266EC21000
• Version / Model: EC2100
• Company Name: Whitney Medical Solutions
• Labeler DUNS: 119676187
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-20
• Public Version: 7
• Public Version Date: 2023-08-28
• Public Version Status: Update
• Public Device Record Key: 7dd55f7f-7f44-4c2a-8d2b-ea03b06bceff

Device Description

The Whitney Medical Solutions’ eShield consists of polyethylene film (and an adhesive pad in some models) with tear guide that allows the cover to be torn fairly straight across it. There is also a double sided tape that is used as a 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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Radiation Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KKX	Drape, Surgical	General, Plastic Surgery	878.4370	2

GMDN Terms

Code	Name	Definition	Implantable	Status
12535	Medical equipment drape, single-use	A flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or equipment components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the contents from soiling and contamination when used in the vicinity of, or entered into, a hygienic area. It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	M266EC21001	HIBCC		25	In Commercial Distribution
Primary	M266EC21000	HIBCC

Premarket Submissions

Submission Number	Supplement Number
K141438	000

Device Sizes

Type	Value	Unit	Text
Width	36	Centimeter
Depth	22	Centimeter
Width	23	Centimeter
Depth	11	Centimeter