FDA.reportPublic FDA data

Storage System

Primary DI
00841436126687
Brand
Storage System
Company
CIVCO MEDICAL INSTRUMENTS CO., INC.
Model
610-2560
Catalog number
610-2560
Device description
General Purpose and Endocavity Ultrasound Probe Cabinet
Published
2026-07-23
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
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
HRECabinet, instrument, ac-powered, ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRECabinet, Instrument, Ac-Powered, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20841436126681Direct MarkingGS10
00841436126687PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2084143612668120841436126681
00841436126687008414361266878414361266870841436126687

GMDN Terms#

Term, Definition table
TermDefinition
Endoscope drying/storage cabinetAn electrically-powered enclosed chamber (the cabinet) designed to dry and store flexible endoscopes and their accessories in an environment that prevents bacterial growth. It uses high-efficiency particulate air (HEPA) inducted into the device and typically heated to 37º Celsius so that the pre-sterilized endoscopes are dried both inside and out. They are then stored within the cabinet under conditions to prevent re-contamination (e.g., under ultraviolet (UV) light) so that they can be directly used without a need for disinfection. It is equipped with a door(s) and shelves to accommodate multiple endoscopes, and is electronically controlled to regulate the drying/storage processes.

Contacts#

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

Regulatory Flags#

DUNS number
134614411
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841436122061Verza Guidance System653-003653-0032026-07-23
00841436122672Needle Guide667-186667-1862026-07-23
00841436125338Biopsy Bracket667-195667-1952026-07-23
00841436125413Tracking Bracket Starter Kit657-106657-1062026-07-23
00841436125444Cradle657-108657-1082026-07-23
00841436125451Classic Stepper657-109657-1092026-07-23
00841436125819Biopsy Bracket642-522642-5222026-07-23
00841436125833Needle Guide Bracket642-524642-5242026-07-23
00841436125857Needle Guide Bracket642-526642-5262026-07-23
00841436126045Verza Guidance System657-110657-1102026-07-23
00841436126281Biopsy Bracket657-116657-1162026-07-23
00841436126304Biopsy Bracket657-118657-1182026-07-23
00841436126656Multi-Purpose Workstation ™ Stepper610-2561610-25612026-07-23
00841436126663Cradle610-2562610-25622026-07-23
00841436126670Storage System610-2559610-25592026-07-23
10841436122662Needle Guide667-188667-188, 667-188-52025-12-31
00841436126311Tracking Bracket Starter Kit657-119657-1192025-12-31
00841436125482Needle Guide11820737118207372026-04-17
00841436108300TEE Kit811-050811-0502017-08-22
00841436108317TEE Kit811-051811-0512017-08-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841436126670Storage SystemCIVCO MEDICAL INSTRUMENTS CO., INC.HRE2026-07-23
00841436122696CAB-TEE Storage SystemCIVCO MEDICAL INSTRUMENTS CO., INC.HRE2022-10-28
00841436122702CAB-VR™ Storage SystemCIVCO MEDICAL INSTRUMENTS CO., INC.HRE2022-10-28
20841436122690CAB-TEE Storage SystemCIVCO MEDICAL INSTRUMENTS CO., INC.HRE2022-10-28
20841436122706CAB-VR™ Storage SystemCIVCO MEDICAL INSTRUMENTS CO., INC.HRE2022-10-28
00841436121156Cabinet Storage SystemCIVCO MEDICAL INSTRUMENTS CO., INC.HRE2021-11-20
00841436121163Cabinet Storage SystemCIVCO MEDICAL INSTRUMENTS CO., INC.HRE2021-11-20
00841436112369Cabinet Storage SystemCIVCO MEDICAL INSTRUMENTS CO., INC.HRE2018-09-25
00841436112376Cabinet Storage SystemCIVCO MEDICAL INSTRUMENTS CO., INC.HRE2018-09-25
20841436112363Cabinet Storage SystemCIVCO MEDICAL INSTRUMENTS CO., INC.HRE2018-09-25
20841436112370Cabinet Storage SystemCIVCO MEDICAL INSTRUMENTS CO., INC.HRE2018-09-25