FDA.reportPublic FDA data

LED Instrument Cover

Primary DI
00841436126366
Brand
LED Instrument Cover
Company
CIVCO MEDICAL INSTRUMENTS CO., INC.
Model
610-2556
Catalog number
610-2556
Device description
Non-sterile (9.5 x 30.5cm) CIV-Clear™ covers for use with THOR LED Lollipop
Published
2026-07-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ILYLamp, infrared, therapeutic heating

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILYLamp, Infrared, Therapeutic HeatingPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841436126366PrimaryGS10
80841436126362Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841436126366008414361263668414361263660841436126366
8084143612636280841436126362

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Away from Sunlight

Contacts#

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

Regulatory Flags#

DUNS number
134614411
Device count
250
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841436122078Biopsy Bracket653-004653-0042026-07-27
00841436122900Biopsy Bracket639-065639-0652026-07-27
00841436124294Biopsy Bracket642-520642-5202026-07-27
00841436125420Tracking Bracket657-107657-1072026-07-27
00841436125895Needle Guide Starter Kit658-009658-0092026-07-27
00841436126052Biopsy Bracket657-111657-1112026-07-27
00841436126212Tracking Bracket Starter Kit657-113657-1132026-07-27
00841436126229Tracking Bracket657-114657-1142026-07-27
00841436126328Tracking Bracket657-120657-1202026-07-27
00841436126403Needle Guide Starter Kit11713007117130072026-07-27
00841436126410Needle Guide Bracket11875211118752112026-07-27
00841436126588Tracking Bracket Starter KitH4927NFH4927NF2026-07-27
00841436126595Tracking Bracket642-528642-5282026-07-27
00841436127028Verza Guidance System11821685118216852026-07-27
00841436127035Biopsy Bracket676-254676-2542026-07-27
10841436125311CIV-Clear™ Transducer Cover610-2512610-2512, 610-2512-52026-07-27
10841436125915Needle Guide867-010867-010, 867-010-52026-07-27
10841436125939Needle Guide857-004857-004, 857-004-52026-07-27
10841436125953Needle Guide842-009842-009, 842-009-52026-07-27
10841436127056Cable SleeveIVL10CS, IVL1CSIVL10CS, IVL1CS2026-07-27

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Primary DI, Brand, Company table
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