FDA.reportPublic FDA data

Safety TPE Tray

Primary DI
20886333215502
Brand
Safety TPE Tray
Company
ARGON MEDICAL DEVICES, INC.
Model
497907
Catalog number
497907
Device description
Safety TPE Tray
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OEZCardiovascular Procedure Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OEZCardiovascular Procedure KitCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20886333215502PackageGS15In Commercial Distribution
00886333215508PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2088633321550220886333215502
00886333215508008863332155088863332155080886333215508

GMDN Terms#

Term, Definition table
TermDefinition
Vascular catheter introduction set, nonimplantableA collection of sterile, nonimplantable, invasive devices intended to provide percutaneous vascular access to enable introduction of a catheter (not included) into the vascular system. It includes a non-steerable introducer sheath with an inner obturator/dilator, and typically an additional access device(s) [e.g., guidewire, introducer needle, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually to enable arterial access. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
140727624
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
true
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
false

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
00884450376867Merit Medical®Merit Medical Systems, Inc.OEZ2026-09-26
00884450431597Merit Medical®Merit Medical Systems, Inc.OEZ2026-09-26
00884450432105Merit Medical®Merit Medical Systems, Inc.OEZ2026-09-26
B098AMS195240Aligned Medical SolutionsAligned Medical SolutionsOEZ2026-09-26
10197106992753CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-25
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10198956541566CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-25
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10198956562035CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-25
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10198956583283CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-25
10198956583320CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-25
10198956583412CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-25
10198956583665CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-25
10198956583726CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-25
10198956584501CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-25
10198956584518CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-25
10198956584839CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-25
10198956585201CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-25