FDA.reportPublic FDA data

eShield Tablet Size

Primary DI
M266EC23001
Brand
eShield Tablet Size
Company
Whitney Medical Solutions
Model
EC2300
Device description
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.
Published
2016-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KKXDrape, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KKXDrape, SurgicalGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K141438000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141438000WHITNEY MEDICAL SOLUTIONS ESHIELDWhitney Medical Solutions2014-08-14KKX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M266EC23001PackageHIBCC25In Commercial Distribution
M266EC23000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Patient surgical drape, single-useA noninvasive sheet designed to cover a portion of a patient’s anatomy during a surgical procedure to function as a barrier to cross contamination (e.g., isolate a site of surgical incision, protect non-operative anatomy). It is not designed with specific heat-reflective or laser resistant materials. It is available in a variety of designs (e.g., flat sheet with or without an access hole, leg tube). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth22Centimeter
Width36Centimeter

Sterilization Methods#

Method table
Method
Radiation Sterilization

Regulatory Flags#

DUNS number
119676187
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M266EC21000eShield Cell Phone SizeEC21002016-09-20
M266EC23000eShield Tablet SizeEC23002016-09-20
M266EC24000eShield SLR Camera SizeEC24002016-09-20
M266OR12010Whitney No-Scratch Curette (Small)OR1201OR12012019-01-07
M266OR12020Whitney No-Scratch Curette (Large)OR1202OR12022019-01-07
M266OR12030Whitney No-Scratch Sculps KnifeOR1203OR12032019-01-07
M266OR12050Whitney No-Scratch Valitome OR1205OR12052019-01-07
M266EC22000eShield Digital Camera SizeEC22002016-09-20
M266EC21001eShield Cell Phone SizeEC21002016-09-20
M266EC22001eShield Digital Camera SizeEC22002016-09-20
M266EC24001eShield SLR Camera SizeEC24002016-09-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08056646500482Oral Surgery PackOMNIA SRLKKX2026-03-27
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10080196025893MEDLINEMEDLINE INDUSTRIES, INC.KKX2022-10-03
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10080196744213MedlineMEDLINE INDUSTRIES, INC.KKX2020-11-11
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10080196747115MedlineMEDLINE INDUSTRIES, INC.KKX2020-11-09