FDA.reportPublic FDA data

Cabinet Storage System

Primary DI
20841436112363
Brand
Cabinet Storage System
Company
CIVCO MEDICAL INSTRUMENTS CO., INC.
Model
CAB-TEE
Catalog number
610-1323
Device description
TEE Probe Cabinet; Holds up to three probes (CAB-TEE)
Published
2018-09-25
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
20841436112363Direct MarkingGS10
00841436112369PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2084143611236320841436112363
00841436112369008414361123698414361123690841436112369

GMDN Terms#

Term, Definition table
TermDefinition
Medical device storage mountA permanently-fixed structure upon which a medical device (not included) is designed to be mounted for storage purposes only; the device is not intended to be operated whilst mounted to this device. It is commonly wall-mounted and may be available in a variety of designs (e.g., wall bracket), may be dedicated to a specific type of device, or non-dedicated; it is not a shelf.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height74Inch
Width24Inch

Sterilization Methods#

Method table
Method

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
00841436125482Needle Guide11820737118207372026-04-17
00841436108300TEE Kit811-050811-0502017-08-22
00841436108317TEE Kit811-051811-0512017-08-22
00841436108324TEE Kit811-052811-0522017-08-22
00841436108331TEE Kit811-053811-0532017-08-22
00841436108348TEE Kit811-054811-0542017-08-22
00841436108355TEE Kit811-055811-0552017-08-22
00841436108362TEE Kit811-056811-0562017-08-22
00841436108379TEE Kit811-057811-0572017-08-22
00841436111133Laparostat810-212810-2122017-08-22
10841436122655Needle Guide667-187667-1872025-12-31
10841436122662Needle Guide667-188667-1882025-12-31
10841436126240Needle Guide610-1557610-15572025-12-31
10841436126257Needle Guide610-1558610-15582025-12-31
00841436122894Verza Guidance System639-064639-0642025-12-31
00841436125345Verza Guidance System667-196667-1962025-12-31
00841436125802Verza Guidance SystemH48062APH48062AP2025-12-31
00841436125826Needle Guidance SystemH48062ARH48062AR2025-12-31
00841436125840Needle Guidance SystemH48062ASH48062AS2025-12-31
00841436126274Verza Guidance System657-115657-1152025-12-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
20841436112370Cabinet Storage SystemCIVCO MEDICAL INSTRUMENTS CO., INC.HRE2018-09-25