FDA.reportPublic FDA data

GUS

Primary DI
00841436112352
Brand
GUS
Company
CIVCO MEDICAL INSTRUMENTS CO., INC.
Model
610-921
Catalog number
610-921
Device description
G10VPL Gus system
Published
2022-01-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
PHTBasin for endoscope reprocessing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PHTBasin For Endoscope ReprocessingGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20841436112356Direct MarkingGS10
00841436112352PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2084143611235620841436112356
00841436112352008414361123528414361123520841436112352

GMDN Terms#

Term, Definition table
TermDefinition
Device sterilization/disinfection container, reusableA receptacle designed to hold wrapped and/or unwrapped medical/dental devices in a chemical washer/disinfector and/or sterilizer during the washing/disinfection and/or sterilization cycle(s). It may be designed as a tray to allow full or partial immersion of the devices in a liquid disinfectant, or as an enclosed box to prevent contamination once the sterilization process is finished. The container may also be used for transport and storage of the processed devices, and may have features such as an expiry date label, breathing filter, built-in slots or inserts to hold instruments, and stacking capabilities. This is a reusable device.

Contacts#

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

Regulatory Flags#

DUNS number
134614411
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

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
00841436126687Storage System610-2560610-25602026-07-23
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840183529239BR Surgical, LLCBR Surgical, LLCPHT2025-09-05
04897129991342CeroFrictSML Med-Tech Solutions LimitedPHT2025-08-12
14897129991349CeroFrictSML Med-Tech Solutions LimitedPHT2025-08-12
04897129991335CeroFrictSML Med-Tech Solutions LimitedPHT2025-08-11
04897129991359CeroFrictSML Med-Tech Solutions LimitedPHT2025-08-11
14897129991332CeroFrictSML Med-Tech Solutions LimitedPHT2025-08-11
14897129991356CeroFrictSML Med-Tech Solutions LimitedPHT2025-08-11
00840183528935BR Surgical, LLCBR Surgical, LLCPHT2024-11-07
00840183528676BR Surgical, LLCBR Surgical, LLCPHT2024-10-21
00840183528683BR Surgical, LLCBR Surgical, LLCPHT2024-10-21
00840183528690BR Surgical, LLCBR Surgical, LLCPHT2024-10-21
00841436113083GUSCIVCO MEDICAL INSTRUMENTS CO., INC.PHT2024-09-09
20841436113087GUSCIVCO MEDICAL INSTRUMENTS CO., INC.PHT2024-09-09
00840183527167BR Surgical, LLCBR Surgical, LLCPHT2024-07-16
00840183505516BR Surgical, LLCBR Surgical, LLCPHT2024-06-24
00840183520199BR Surgical, LLCBR Surgical, LLCPHT2024-06-24
00840183525699BR Surgical, LLCBR Surgical, LLCPHT2024-06-11
00840183500146BR Surgical, LLCBR Surgical, LLCPHT2024-06-10
00840183500603BR Surgical, LLCBR Surgical, LLCPHT2024-06-10
00840183500726BR Surgical, LLCBR Surgical, LLCPHT2024-06-10
00840183500771BR Surgical, LLCBR Surgical, LLCPHT2024-06-10
00840183500795BR Surgical, LLCBR Surgical, LLCPHT2024-06-10
00840183501334BR Surgical, LLCBR Surgical, LLCPHT2024-06-10
00840183501549BR Surgical, LLCBR Surgical, LLCPHT2024-06-10
00840183504113BR Surgical, LLCBR Surgical, LLCPHT2024-06-10
00840183504182BR Surgical, LLCBR Surgical, LLCPHT2024-06-10
00840183505110BR Surgical, LLCBR Surgical, LLCPHT2024-06-10
00840183506988BR Surgical, LLCBR Surgical, LLCPHT2024-06-10
00840183510114BR Surgical, LLCBR Surgical, LLCPHT2024-06-10
00840183511845BR Surgical, LLCBR Surgical, LLCPHT2024-06-10