FDA.reportPublic FDA data

Screw Dilator

Primary DI
00886333004928
Brand
Screw Dilator
Company
ARGON MEDICAL DEVICES, INC.
Model
630938025
Catalog number
630938025
Device description
Screw Dilator 9F x 25cm
Published
2016-09-12
Public version status
Update
Distribution status
Not 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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K990808000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K990808000PBN DILATORSMedical Device Technologies, Inc.1999-11-26FGE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20886333004922PackageGS110Not in Commercial Distribution
00886333004928PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2088633300492220886333004922
00886333004928008863330049288863330049280886333004928

GMDN Terms#

Term, Definition table
TermDefinition
Fascial tissue dilator, single-useA surgical instrument used for stretching or enlarging the fascial tissue covering a cavity, tract, or opening typically prior to the introduction of a catheter during an invasive diagnostic or interventional procedure (e.g., femoral artery catheterization). It is a rod-like device with a long, slender, hollow or solid body and a rounded nose, inflatable balloon or screw-tip at its distal end, that is available in a variety of sizes and typically made of metal or plastic. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Contacts#

Phone, Email table
PhoneEmail
1.800.927.4669Customer.Service@argonmedical.com

Regulatory Flags#

DUNS number
140727624
Device count
1
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
00886333003594Breast Localization Needles231075G231075G2022-07-05
00886333003600Breast Localization Needles231030G231030G2022-07-05
00886333003617Breast Localization Needles231050G231050G2022-07-05
00886333003624Breast Localization Needles231125G231125G2022-07-05
00886333003631Breast Localization Needles231100G231100G2022-07-05
00886333003648Breast Localization Needles2420502420502022-06-30
00886333003655Breast Localization Needles2420752420752022-06-30
00886333003662Breast Localization Needles2421002421002022-06-30
00886333003679Breast Localization Needles2421252421252022-06-29
00886333003686Breast Localization Needles2430752430752022-06-29
00886333003693Breast Localization Needles2431252431252022-07-05
00886333003709Breast Localization Needles2430502430502022-06-29
00886333003723Breast Localization Needles2430302430302022-06-29
00886333003730Breast Localization Needles2440302440302022-06-30
00886333003747Breast Localization Needles2440502440502022-06-30
00886333003754Breast Localization Needles2440752440752022-06-29
00886333003761Breast Localization Needles2441002441002022-06-30
00886333003778Breast Localization Needles2441252441252022-06-30
00886333003785Breast Localization Needles2511002511002022-06-29
00886333003792Breast Localization Needles2510752510752022-07-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450440476ByrdMerit Medical Systems, Inc.GCC2026-08-21
00884450440483ByrdMerit Medical Systems, Inc.GCC2026-08-21
00884450440506ByrdMerit Medical Systems, Inc.GCC2026-08-21
00884450440513ByrdMerit Medical Systems, Inc.GCC2026-08-21
00884450440520ByrdMerit Medical Systems, Inc.GCC2026-08-21
00884450440537ByrdMerit Medical Systems, Inc.GCC2026-08-21
00884450440568ByrdMerit Medical Systems, Inc.GCC2026-08-21
00884450440575ByrdMerit Medical Systems, Inc.GCC2026-08-21
00884450440582ByrdMerit Medical Systems, Inc.GCC2026-08-21
00884450440599ByrdMerit Medical Systems, Inc.GCC2026-08-21
B382SD916130120Surgical DirectSurgical Direct, Inc.GCC2026-07-28
00810212930404SURGIPROSSurgipros, LLCGCC2026-05-28
00810212930411SURGIPROSSurgipros, LLCGCC2026-05-28
00810212930428SURGIPROSSurgipros, LLCGCC2026-05-28
00810212930435SURGIPROSSurgipros, LLCGCC2026-05-28
00810212930442SURGIPROSSurgipros, LLCGCC2026-05-28
00810212930459SURGIPROSSurgipros, LLCGCC2026-05-28
00810212933504SURGIPROSSurgipros, LLCGCC2026-05-28
00810212933511SURGIPROSSurgipros, LLCGCC2026-05-28
00810212933528SURGIPROSSurgipros, LLCGCC2026-05-28
00810212933535SURGIPROSSurgipros, LLCGCC2026-05-28
00810212933542SURGIPROSSurgipros, LLCGCC2026-05-28
00810212933559SURGIPROSSurgipros, LLCGCC2026-05-28
00810212933566SURGIPROSSurgipros, LLCGCC2026-05-28
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