FDA.reportPublic FDA data

MINI DILATOR SET 1.0,1.5,2.0,2.5 &3.0MM

Primary DI
G422DL0030
Brand
MINI DILATOR SET 1.0,1.5,2.0,2.5 &3.0MM
Company
BIOPSY FINE CUT INSTRUMENTS
Model
DL003
Catalog number
DL003
Device description
MINI DILATOR SET 1.0,1.5,2.0,2.5 &3.0MM
Published
2023-10-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
KCFDilator, Esophageal, Ent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KCFDilator, Esophageal, EntEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G422DL0030PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Urethral sound, reusableA hand-held manual surgical instrument designed to explore and measure the urethra. It is a slender hollow or solid cylindrical instrument made of metal or plastic typically with graduations of length displayed along its working end. It is typically available in a range of sizes and flexibilities. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
645680898
Device count
1
Premarket exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G422BP0110TISCHLER OVAL 21CMBP011BP0112024-10-03
G422SP0030GRAVES VAG SPEC LG 4.5SP003SP0032024-10-03
G422BP0120TISCHLER KEVORKIAN BIOPSY PUNCHBP012BP0122023-11-28
G422BP0180"TISCHLER MORGAN BIOPSY PUNCH 10"""BP018BP0182023-10-13
G422BP0190"BABY TISCHLER BIOPSY PUNCH 10"""BP019BP0192023-10-13
G422BP1090"ROTO TISCHLER BIOPSY PUNCH 10"""BP109BP1092023-10-13
G422BP0181TISCHLER MORGAN BIOPSY PUNCH 10"BP018BP0182023-10-13
G422BP0191BABY TISCHLER BIOPSY PUNCH 10"BP019BP0192023-10-13
G422BP1091ROTO TISCHLER BIOPSY PUNCH 10"BP109BP1092023-10-13
G422DL1010DILATOR CERVICAL SET OF 6DL101DL1012023-10-13
G422DL3000HANK DILATOR DOUBLE ENDED 7/8 FRDL300DL3002023-10-13
G422DL3010HANK DILATOR SET OF 6 (Z304)DL301DL3012023-10-13
G422FC0060INSTRUMENT F. REMOVAL OF I.U.D FC006FC0062023-10-13
G422LZ1080"Lletz TENACULUM FORCEPS 9.5"""LZ108LZ1082023-10-13
G422SP1040PEDERSON SPECULUM MEDIUMSP104SP1042023-10-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08906039312096OSSEOUS Salivary by Pass TubeEON MEDITECH PRIVATE LIMITEDKCF2024-07-04
08906039312102OSSEOUS Salivary by Pass TubeEON MEDITECH PRIVATE LIMITEDKCF2024-07-04
08906039312119OSSEOUS Salivary by Pass TubeEON MEDITECH PRIVATE LIMITEDKCF2024-07-04
08906039312126OSSEOUS Salivary by Pass TubeEON MEDITECH PRIVATE LIMITEDKCF2024-07-04
08906039312133OSSEOUS Salivary by Pass TubeEON MEDITECH PRIVATE LIMITEDKCF2024-07-04
08906039312140OSSEOUS Salivary by Pass TubeEON MEDITECH PRIVATE LIMITEDKCF2024-07-04
08906039314366OSSEOUS Salivary by Pass TubeEON MEDITECH PRIVATE LIMITEDKCF2024-07-04
08906039314342OSSEOUS Salivary by Pass TubeEON MEDITECH PRIVATE LIMITEDKCF2024-07-04
08906039314328OSSEOUS Salivary by Pass TubeEON MEDITECH PRIVATE LIMITEDKCF2024-07-04
08906039314304OSSEOUS Salivary by Pass TubeEON MEDITECH PRIVATE LIMITEDKCF2024-07-04
08906039314281OSSEOUS Salivary by Pass TubeEON MEDITECH PRIVATE LIMITEDKCF2024-07-04
08906039314267OSSEOUS Salivary by Pass TubeEON MEDITECH PRIVATE LIMITEDKCF2024-07-04
G422DL1010DILATOR CERVICAL SET OF 6BIOPSY FINE CUT INSTRUMENTSKCF2023-10-13
G422DL3000HANK DILATOR DOUBLE ENDED 7/8 FRBIOPSY FINE CUT INSTRUMENTSKCF2023-10-13
G422DL3010HANK DILATOR SET OF 6 (Z304)BIOPSY FINE CUT INSTRUMENTSKCF2023-10-13
00827002352674HerculesCOOK INCORPORATEDKCF2022-12-20
00827002352681HerculesCOOK INCORPORATEDKCF2022-12-20
00827002352698HerculesCOOK INCORPORATEDKCF2022-12-20
00827002352704HerculesCOOK INCORPORATEDKCF2022-12-20
00827002352711HerculesCOOK INCORPORATEDKCF2022-12-20
14063107100281Montgomery® Esophageal TubeBoston Medical Products, Inc.KCF2022-09-29
14063107100298Montgomery® Esophageal TubeBoston Medical Products, Inc.KCF2022-09-29
14063107100304Montgomery® Salivary Bypass TubeBoston Medical Products, Inc.KCF2022-09-29
14063107100311Montgomery® Salivary Bypass TubeBoston Medical Products, Inc.KCF2022-09-29
14063107100328Montgomery® Salivary Bypass TubeBoston Medical Products, Inc.KCF2022-09-29
14063107100335Montgomery® Salivary Bypass TubeBoston Medical Products, Inc.KCF2022-09-29
14063107100342Montgomery® Salivary Bypass TubeBoston Medical Products, Inc.KCF2022-09-29
14063107100359Montgomery® Salivary Bypass TubeBoston Medical Products, Inc.KCF2022-09-29
14063107100366Montgomery® Salivary Bypass TubeBoston Medical Products, Inc.KCF2022-09-29
14063107100373Montgomery® Salivary Bypass TubeBoston Medical Products, Inc.KCF2022-09-29