FDA.reportPublic FDA data

Rabinov

Primary DI
00827002013223
Brand
Rabinov
Company
COOK INCORPORATED
Model
G01322
Catalog number
SCS-P-16-S
Device description
Rabinov Sialography Set
Published
2020-10-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OAJcatheter, drainage, intraoral/extraoral

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OAJCatheter, Drainage, Intraoral/ExtraoralGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00827002013223PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00827002013223008270020132238270020132230827002013223

GMDN Terms#

Term, Definition table
TermDefinition
Salivary gland catheterA sterile, thin flexible tube intended to be used to access the salivary glands typically to introduce a contrast medium to enhance the radiographic images of the glands during sialography. It is typically made of metal or plastic materials [e.g., polyethylene (PE), polyurethane] and will have a short length of rigid or flexible cannula extending from its distal end. This device may also be used for intraoperative cholangiography. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in dark, dry, cool place.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(812)330-5494sharedservices@cookmedical.com

Regulatory Flags#

DUNS number
042823948
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00827002011939KopansG01193DKBL-20-15.02020-10-02
00827002012585KopansG01258DKBL-21-15.02020-10-02
00827002025547KopansG02554DKBL-21-9.0-A2020-10-02
00827002025868KopansG02586DKBL-20-5.0-A2020-10-02
00827002025875KopansG02587DKBL-20-9.0-A2020-10-02
00827002026018KopansG02601DKBL-20-7.0-A2020-10-02
00827002028500KopansG02850DKBL-20-15.0-A2020-10-02
00827002029002KopansG02900DKBL-21-5.0-A2020-10-02
00827002029385KopansG02938DKBL-21-15.0-A2020-10-02
00827002035072KopansG03507DKBL-21-7.0-A2020-10-02
00827002037953KopansG03795DKBL-20-11.0-A2020-10-02
00827002042933KopansG04293DKBL-20-15.0-U2020-10-02
00827002042964KopansG04296DKBL-20-9.0-A-U2020-10-02
00827002043435KopansG04343DKBL-20-5.0-A-U2020-10-02
00827002053465KopansG05346DKBL-21-11.0-A2020-10-02
00827002058620KopansG05862DKBL-21-5.0-A-U2020-10-02
00827002073708KopansG07370DKBL-21-9.0-A-U2020-10-02
00827002090422KopansG09042DKBL-21-7.0-A-U2020-10-02
00827002099845KopansG09984DKBL-20-7.0-A-U2020-10-02
00827002099852KopansG09985DKBL-20-15.0-A-U2020-10-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850007350345Kolenda Salivary Introducer Set - 5.0C2DX, INC.OAJ2026-02-10
00850007350352Kolenda Salivary Introducer Set - 6.0C2DX, INC.OAJ2026-02-10
00850007350383Sialocath Salivary Duct CatheterC2DX, INC.OAJ2026-02-10
00827002007406Yune-KlatteCOOK INCORPORATEDOAJ2020-10-02
00827002007413Yune-KlatteCOOK INCORPORATEDOAJ2020-10-02
00827002011144ManashilCOOK INCORPORATEDOAJ2020-10-02
00827002011151ManashilCOOK INCORPORATEDOAJ2020-10-02
00827002011168ManashilCOOK INCORPORATEDOAJ2020-10-02
00827002013216RabinovCOOK INCORPORATEDOAJ2020-10-02
00827002013230RabinovCOOK INCORPORATEDOAJ2020-10-02
00827002013445RabinovCOOK INCORPORATEDOAJ2020-10-02
00827002013452RabinovCOOK INCORPORATEDOAJ2020-10-02
00827002013469RabinovCOOK INCORPORATEDOAJ2020-10-02
00827002013476RabinovCOOK INCORPORATEDOAJ2020-10-02
00827002013544ManashilCOOK INCORPORATEDOAJ2020-10-02
00827002013629RabinovCOOK INCORPORATEDOAJ2020-10-02
00827002241299KolendaCOOK INCORPORATEDOAJ2020-10-02
00827002241329KolendaCOOK INCORPORATEDOAJ2020-10-02
00827002351660SialoCathCOOK INCORPORATEDOAJ2020-10-02