FDA.reportPublic FDA data

TEE Kit

Primary DI
00841436108348
Brand
TEE Kit
Company
CIVCO MEDICAL INSTRUMENTS CO., INC.
Model
811-054
Catalog number
811-054
Device description
Rail Adapter, TEE Transducer Holder
Published
2017-08-22
Public version status
Update
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
GDJCLAMP, SURGICAL, GENERAL & PLASTIC SURGERY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDJClamp, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841436108348PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841436108348008414361083488414361083480841436108348

GMDN Terms#

Term, Definition table
TermDefinition
Surgical camera holderA device designed to hold or stabilize a video camera or endoscope while recording a surgical operative procedure. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height3.3Inch
Length4.5Inch

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
false
Manufacturing date on label
true
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
20841436122881Verza Guidance System639-064639-0642025-12-31
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20841436125516Verza Guidance SystemH48062APH48062AP2025-12-31
20841436125523Needle Guidance SystemH48062ARH48062AR2025-12-31
20841436125530Needle Guidance SystemH48062ASH48062AS2025-12-31
20841436126261Verza Guidance System657-115657-1152025-12-31
20841436126339Verza Guidance System657-117657-1172025-12-31
20841436126346Tracking Bracket Starter Kit657-119657-1192025-12-31
20841436124274Verza Guidance SystemH48062AVH48062AV2025-12-31
00841436122658Needle Guide667-187667-1872025-12-31
00841436122665Needle Guide667-188667-1882025-12-31
00841436126243Needle Guide610-1557610-15572025-12-31
00841436126250Needle Guide610-1558610-15582025-12-31
20841436113087GUS610-2159610-21592024-09-09
20841436122980Biopsy Bracket644-105644-1052024-09-09
20841436125066Biopsy Bracket639-072639-0722024-09-09
20841436122140Biopsy Bracket653-006653-0062024-06-20
20841436123284Needle Guide Bracket676-243676-2432024-06-20
00841436122214Needle Guide842-001842-001, 842-001-52024-06-20
00841436123051Needle Guide842-002842-002, 842-002-52024-06-20

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Primary DI, Brand, Company table
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