FDA.reportPublic FDA data

TYPENEX

Primary DI
00840368514364
Brand
TYPENEX
Company
SOL-MILLENNIUM MEDICAL INC
Model
MS2203
Catalog number
MS2203
Device description
INTRODUCER SET
Published
2024-01-04
Public version status
New
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
DYBIntroducer, Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYBIntroducer, CatheterCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840368514364PackageGS15In Commercial Distribution
00840368514371PackageGS1200In Commercial Distribution
00840368514357PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840368514364008403685143648403685143640840368514364
00840368514371008403685143718403685143710840368514371
00840368514357008403685143578403685143570840368514357

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Introducer Sheath Compatibilit7French

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
833-637-0857info@solm.com

Regulatory Flags#

DUNS number
069590113
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
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
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840368517099TYPENEX MS2012PMS2012P2024-05-10
00840368516542TYPENEX MS2003MS20032024-04-15
20818392014666SOL-CARE Safety Multi-Sample Needle SMSN211252019-10-16
20818392014680SOL-CARE Safety Multi-Sample Needle SMSN221252019-10-16
20818392014956SOL-CARE Safety Multi-Sample Needle with Pre-attached Holder SMSNH211252019-10-16
20818392014970SOL-CARE Safety Multi-Sample Needle with Pre-attached Holder SMSNH221252019-10-16
20818392018596SOL-CARE Safety NeedlePSN21102019-04-12
10818392018612SOL-CARE Safety NeedlePSN22102019-04-12
20818392018749SOL-CARE Safety NeedlePSN30122019-04-12
10818392018452SOL-CARE Safety NeedlePSN18152019-04-10
10818392018537SOL-CARE Safety NeedlePSN22152019-04-10
10818392018568SOL-CARE Safety NeedlePSN25152019-04-10
10818392018629SOL-CARE Safety NeedlePSN23102019-04-10
20818392018664SOL-CARE Safety NeedlePSN25582019-04-10
20818392018671SOL-CARE Safety NeedlePSN25102019-04-10
10818392018728SOL-CARE Safety NeedlePSN27122019-04-10
10818392010401SOL-CARE™ Safety NeedleSN30122016-09-16
10818392010432SOL-CARE™ Safety NeedleSN27582016-09-16
20818392010446SOL-CARE™ Safety NeedleSN27122016-09-16
20818392010453SOL-CARE™ Safety NeedleSN26382016-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450840597Prelude Roadster™Merit Medical Systems, Inc.DYB2026-08-27
06974949030920CorPassTM Introducer Sheath SetCardiocycle Medical (Suzhou) Co., LtdDYB2026-08-27
06974949030944CorPassTM Introducer Sheath SetCardiocycle Medical (Suzhou) Co., LtdDYB2026-08-27
10801902227246ARROWTELEFLEX INCORPORATEDDYB2026-08-27
10884450119836Prelude EASE™Merit Medical Systems, Inc.DYB2026-08-27
00884450838211Prelude Roadster™Merit Medical Systems, Inc.DYB2026-08-18
00199874352930Transseptal Puncture DevicePROTARYX MEDICAL INC.DYB2026-07-15
00198715836998EMPOWER™ INTRODUCER SHEATH WITH HYDROPHILIC COATINGFREUDENBERG MEDICAL, LLCDYB2026-01-29
00850291007260Intri24 Introducer SheathInari Medical, Inc.DYB2023-03-20
10801902190519ARROWTELEFLEX INCORPORATEDDYB2021-09-02
04251244500641DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2021-04-20
04251244500719DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2021-04-20
04251244500801DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2021-04-20
04251244500818DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2021-04-20
04251244500832DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2021-04-20
04251244500849DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2021-04-20
04251244500856DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2021-04-20
04251244501099DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2021-04-20
04251244501075DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2021-04-20
04251244501082DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2021-04-20
04251244500795DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2020-11-04
00389701012353R2P Destination SlenderTERUMO MEDICAL CORPORATIONDYB2020-04-10
00389701012360R2P Destination SlenderTERUMO MEDICAL CORPORATIONDYB2020-04-10
00389701012377R2P Destination SlenderTERUMO MEDICAL CORPORATIONDYB2020-04-10
00389701012384R2P Destination SlenderTERUMO MEDICAL CORPORATIONDYB2020-04-10
04251244500108DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2019-06-30
04251244500115DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2019-06-30
04251244500122DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2019-06-30
04251244500139DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2019-06-30
04251244500146DuraSheath Introducer Sheath SystemContract Medical International GmbHDYB2019-06-30