FDA.reportPublic FDA data

MediClear PreOp

Primary DI
00825439013007
Brand
MediClear PreOp
Company
Covalon Technologies Ltd
Model
7000625
Device description
Antimicrobial silicone film drape
Published
2022-12-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
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
K163556000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K163556000MediClear PreOpCovalontechnologies, Inc.2017-09-14KKX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00825439013007PackageGS125In Commercial Distribution
10825439013011PackageGS14In Commercial Distribution
00825439012994PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00825439013007008254390130078254390130070825439013007
1082543901301110825439013011
00825439012994008254390129948254390129940825439012994

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 or an adhesive film sheet otherwise known as an incise drape). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
206936101
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
true
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00825439012062MediClear™ Scar 10x10900101090010102023-07-14
00825439012260MediClear™ Scar 4x4900040490004042023-07-14
00825439012291MediClear™ Scar 6x7900060790006072023-07-14
00825439012321MediClear™ Scar 6x30900063090006302023-07-14
00825439012789MediClear™ PreOp 70010122018-04-30
00825439012819MediClear PreOp70006302022-12-01
00825439012994MediClear PreOp70006252022-12-01
00825439016169MediClear™ PreOp70008302018-05-18
00825439012871MediClear™ PreOp70006072018-04-30
00825439010136IV Clear 4x4 with crosshairTWBD10112022-11-30
00825439010334SurgiClear 4x4TWBD10222022-12-01
00825439010464IV Clear 4x4TWBD10132022-11-30
00825439011188"ColActive® Plus 2""x2"""55502202022-11-30
00825439011218"ColActive® Plus 4""x4"""55504402022-11-30
00825439011249"ColActive® Plus 7""x7"""55507702022-11-30
00825439011270"ColActive® Plus Ag 2""x2"""55512202022-11-30
00825439011300"ColActive® Plus Ag 4""x4"""55514402022-11-30
00825439011331"ColActive® Plus Ag 7""x7"""55517702022-11-30
00825439013472ColActive® Transfer 4x455504412022-12-05
00825439017241ColActive® Plus Powder80P00012022-11-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08056646500291Basic Implant SetOMNIA SRLKKX2026-03-27
08056646500307Implantology SetOMNIA SRLKKX2026-03-27
08056646500321Oral Surgery SetOMNIA SRLKKX2026-03-27
08056646500482Oral Surgery PackOMNIA SRLKKX2026-03-27
10812564036022MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
10812564036077MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
10812564036107MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
10812564036183MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
10812564036190MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
10812564036213MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
10812564036381MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
20080196017017MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
20888277636726MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
20888277660943MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
20888277660950MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
40884389185781MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
20888277635552MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-10
40888277357038MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-10
10080196176700Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196496648Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196496655Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196496686Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196497164Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196497171Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196497188Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196497195Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196497720Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196497744Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196498239Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196498376Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29