FDA.reportPublic FDA data

Cord Cover

Primary DI
10841436101407
Brand
Cord Cover
Company
CIVCO MEDICAL INSTRUMENTS CO., INC.
Model
610-024
Catalog number
610-024
Device description
Sterile (7.6 x 244cm) polyethylene cover
Published
2017-08-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

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
K943393000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K943393000CIVCO PROBE BOOT/CORD COVERCIVCO Medical Instruments Co., Inc.1995-02-02KKX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841436101400PackageGS124In Commercial Distribution
10841436101407PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841436101400008414361014008414361014000841436101400
1084143610140710841436101407

GMDN Terms#

Term, Definition table
TermDefinition
Medical equipment/instrument drape, single-useA flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment/instrument (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the equipment/instrument from soiling and/or contamination when used inside, or within the vicinity of, a hygienic area; it may have patient contact, however it is not intended to be introduced into a body cavity (noninvasive). It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length96Inch
Width3Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Away from Sunlight
Storage Environment Temperature52 Degrees Fahrenheit85 Degrees Fahrenheit

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
+1(319)248-6502regulatory@civco.com

Regulatory Flags#

DUNS number
134614411
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841436125420Tracking Bracket657-107657-1072026-07-27
00841436126212Tracking Bracket Starter Kit657-113657-1132026-07-27
00841436126229Tracking Bracket657-114657-1142026-07-27
00841436126328Tracking Bracket657-120657-1202026-07-27
00841436126588Tracking Bracket Starter KitH4927NFH4927NF2026-07-27
00841436126595Tracking Bracket642-528642-5282026-07-27
00841436125413Tracking Bracket Starter Kit657-106657-1062026-07-23
10841436101865eTRAX™ Needle610-1057610-10572017-08-29
10841436101889VirtuTRAX Instrument Navigator610-1059610-10592017-08-22
10841436102282VirtuTRAX Instrument Navigator610-1153610-11532017-08-22
10841436102435eTRAX™ Needle610-1213-10610-1213-102017-08-29
10841436102534eTRAX™ Needle610-1217-10610-1217-102017-08-29
10841436102640omniTRAX Patient Tracker610-1228610-12282017-08-22
10841436103128omniTRAX Active Patient Tracker610-1306610-13062017-08-22
10841436103289eTRAX™ Needle610-1413-10610-1413-102017-08-29
10841436103302eTRAX™ Needle610-1417-10610-1417-102017-08-29
10841436103395eTRAX™ Needle610-1613-10610-1613-102017-08-29
10841436103418eTRAX™ Needle610-1615-10610-1615-102017-08-29
10841436103531eTRAX™ Needle610-1815-10610-1815-102017-08-29
10841436103555eTRAX™ Needle610-1818-10610-1818-102017-08-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06975424191006Exact Medical Manufacturing, Inc.EXACT MEDICAL MANUFACTURING, INC.KKX2026-09-21
10801902196665ARROWTELEFLEX INCORPORATEDKKX2026-07-28
06975424190771Exact Medical Manufacturing, Inc.EXACT MEDICAL MANUFACTURING, INC.KKX2026-07-16
00628110259448MolecuLightDX Sterile Surgical Sleeve Convenience Kit of 25MolecuLight IncKKX2026-07-08
10801902225808ARROWTELEFLEX INCORPORATEDKKX2026-05-06
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
06975085709480Exact Medical Manufacturing, Inc.EXACT MEDICAL MANUFACTURING, INC.KKX2024-07-12
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