FDA.reportPublic FDA data

Cook

Primary DI
00827002034662
Brand
Cook
Company
COOK INCORPORATED
Model
G03466
Catalog number
SDD-100
Device description
Salivary Duct Dilator
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
GCCDilator, catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCCDilator, CatheterGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00827002034662PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00827002034662008270020346628270020346620827002034662

GMDN Terms#

Term, Definition table
TermDefinition
Salivary gland dilator, single-useA sterile surgical instrument used during ear/nose/throat (ENT) surgery for enlarging a salivary gland cavity, canal, or duct, typically prior to the introduction of a catheter during an invasive diagnostic or interventional procedure. It is rod-like device, with a long, very slender body and a rounded nose at its distal end that is made of metal (e.g., stainless steel). 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
00827002000766CookG00076MDC-62020-10-02
00827002000773CookG00077MDC-72020-10-02
00827002000780CookG00078MDC-82020-10-02
00827002009653CookG00965MDC-102020-10-02
00827002009660CookG00966MDC-52020-10-02
00827002010796CookG01079MDC-92020-10-02
00827002013209CookG01320MDC-122020-10-02
00827002014626CookG01462MDC-142020-10-02
00827002016170CookG01617MDC-162020-10-02
00827002026896CookG02689MDC-42020-10-02
00827002027350CookG02735MDC-32020-10-02
00827002048881CookG04888FD-1002020-10-02
00827002541900GuardiaG54190J-UOB-40282016-09-24
00827002541917GuardiaG54191J-UOB-4028-ST2016-09-24
00827002614994MagniCoreG61499MRCHN-20-15.02026-03-27
00827002615007MagniCoreG61500MRCHN-18-10.02026-03-27
00827002615014MagniCoreG61501MRCHN-18-15.02026-03-27
00827002615021MagniCoreG61502MRCHN-18-20.02026-03-27
00827002615038MagniCoreG61503MRCHN-20-10.02026-03-27
00827002615045MagniCoreG61504MRCHN-20-20.02026-03-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850007350338Salivary Access Dilator SetC2DX, INC.GCC2026-02-10
00194613099848MSI Precision Specialty InstrumentsMed Saver, Inc.GCC2025-08-01
00194613094942MSI Precision Specialty InstrumentsMed Saver, Inc.GCC2024-08-15
00840183501945BR Surgical, LLCBR Surgical, LLCGCC2024-01-31
G586UR96282190Novo SurgicalNOVO SURGICAL, INC.GCC2023-12-18
G586UR96282210Novo SurgicalNOVO SURGICAL, INC.GCC2023-12-18
G586UR96282230Novo SurgicalNOVO SURGICAL, INC.GCC2023-12-18
G586UR96282250Novo SurgicalNOVO SURGICAL, INC.GCC2023-12-18
G586UR96282270Novo SurgicalNOVO SURGICAL, INC.GCC2023-12-18
G586UR96282290Novo SurgicalNOVO SURGICAL, INC.GCC2023-12-18
G586UR96282310Novo SurgicalNOVO SURGICAL, INC.GCC2023-12-18
00840343718312GEN2SURGIX MEDICAL LLCGCC2023-09-05
00842331192661Novo Surgical IncNOVO SURGICAL, INC.GCC2023-08-14
00842331192678Novo Surgical IncNOVO SURGICAL, INC.GCC2023-08-14
00842331192685Novo Surgical IncNOVO SURGICAL, INC.GCC2023-08-14
00842331192692Novo Surgical IncNOVO SURGICAL, INC.GCC2023-08-14
00842331192708Novo Surgical IncNOVO SURGICAL, INC.GCC2023-08-14
00840329829445Black & Black SurgicalBLACK & BLACK SURGICAL, INC.GCC2023-05-10
00842962125571HNM MEDICALHNM STAINLESS, LLC.GCC2023-04-03
00842962125526HNM MEDICALHNM STAINLESS, LLC.GCC2023-03-29
00842962125533HNM MEDICALHNM STAINLESS, LLC.GCC2023-03-29
00842962125540HNM MEDICALHNM STAINLESS, LLC.GCC2023-03-29
00842962125557HNM MEDICALHNM STAINLESS, LLC.GCC2023-03-29
00842962125564HNM MEDICALHNM STAINLESS, LLC.GCC2023-03-29
00842962124345HNM MEDICALHNM STAINLESS, LLC.GCC2023-03-23
00842962124352HNM MEDICALHNM STAINLESS, LLC.GCC2023-03-23
00842962124369HNM MEDICALHNM STAINLESS, LLC.GCC2023-03-23
00842962124376HNM MEDICALHNM STAINLESS, LLC.GCC2023-03-23
00842962124383HNM MEDICALHNM STAINLESS, LLC.GCC2023-03-23
00842962124390HNM MEDICALHNM STAINLESS, LLC.GCC2023-03-23