FDA.reportPublic FDA data

GLIDESHEATH

Primary DI
50389701011122
Brand
GLIDESHEATH
Company
TERUMO MEDICAL CORPORATION
Model
20-1055
Catalog number
20-1055
Device description
GLIDESHEATH SS Kit Hydrophilic Coated Introducer Sheath
Published
2016-09-24
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
DYBINTRODUCER, CATHETER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYBIntroducer, CatheterCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30389701011128PackageGS15In Commercial Distribution
50389701011122PackageGS110In Commercial Distribution
00389701011127PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3038970101112830389701011128
5038970101112250389701011122
00389701011127003897010111273897010111270389701011127

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
Catheter Gauge5French
Device Size Text, specify0
Device Size Text, specify0
Length10Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Avoid direct sunlight. Keep Dry.
Special Storage Condition, Specify00Do not store at extreme temperature and humidity

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)283-7866tmccustomer.admin@terumomedical.com

Regulatory Flags#

DUNS number
131489882
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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
50389701012891R2P NAVICROSSSC-R35STR200SC-R35STR2002024-01-11
50389701012907R2P NAVICROSSSC-R35ANG200SC-R35ANG2002024-01-11
00389701012469TR BANDTRB24-REGTRB24-REG2022-10-07
00389701012476TR BANDTRB29-LRGTRB29-LRG2022-10-07
50389701012358R2P Destination SlenderGS-R6ST1C10WGS-R6ST1C10W2020-04-10
50389701012365R2P Destination SlenderGS-R6ST1C75WGS-R6ST1C75W2020-04-10
50389701012372R2P Destination SlenderGS-R6ST1C85WGS-R6ST1C85W2020-04-10
50389701012389R2P Destination SlenderGS-R6ST1C95WGS-R6ST1C95W2020-04-10
50389701012136SOLOPATHSTFI-1425STFI-14252018-05-17
50389701012143SOLOPATHSTFI-1435STFI-14352018-05-17
50389701012150SOLOPATHSTFI-1625STFI-16252018-05-17
50389701012167SOLOPATHSTFI-1635STFI-16352018-05-17
50389701012174SOLOPATHSTFI-1825STFI-18252018-05-17
50389701012181SOLOPATHSTFI-1835STFI-18352018-05-17
50389701012198SOLOPATHSTFI-1925STFI-19252018-05-17
50389701012204SOLOPATHSTFI-1935STFI-19352018-05-17
50389701012211SOLOPATHSTFI-2125STFI-21252018-05-17
50389701012228SOLOPATHSTFI-2135STFI-21352018-05-17
50389701012235SOLOPATHSR-1925SR-19252018-05-17
50389701012242SOLOPATHSR-1935SR-19352018-05-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00849884007541VYGONVygon CorporationDYB2026-05-22
00849884007558VYGONVygon CorporationDYB2026-05-22
20886333227864V-Stick Vascular Access SetARGON MEDICAL DEVICES, INC.DYB2026-03-20
20886333227871V-Stick Vascular Access SetARGON MEDICAL DEVICES, INC.DYB2026-03-20
20886333227888V-Stick Vascular Access Set ARGON MEDICAL DEVICES, INC.DYB2026-03-20
20886333227895V-Stick Vascular Access SetARGON MEDICAL DEVICES, INC.DYB2026-03-20
20886333227901V-Stick Vascular Access Set ARGON MEDICAL DEVICES, INC.DYB2026-03-20
20886333227918V- Stick Vascular Access SetARGON MEDICAL DEVICES, INC.DYB2026-03-20
20886333227925V-Stick Vascular Access SetARGON MEDICAL DEVICES, INC.DYB2026-03-20
20886333227932V-Stick Vascular Access SetARGON MEDICAL DEVICES, INC.DYB2026-03-20
00813502010411Impella RP Flex Introducer KitAbiomed, Inc.DYB2026-03-11
00813502011685Abiomed Impella CP 14Fr Introducer KitAbiomed, Inc.DYB2026-03-11
00813502011692Abiomed Impella CP 14Fr Introducer Kit Abiomed, Inc.DYB2026-03-11
20801902225508ARROWTELEFLEX INCORPORATEDDYB2026-03-11
20801902225546ARROWTELEFLEX INCORPORATEDDYB2026-03-11
00840479401263enableCV Introducer SheathENABLECV INC.DYB2026-02-26
20884450113992Prelude IDeal™Merit Medical Systems, Inc.DYB2026-02-25
20884450115804Prelude IDeal™Merit Medical Systems, Inc.DYB2026-02-25
00884450489642Prelude SNAP™Merit Medical Systems, Inc.DYB2026-02-21
30884908188456MICRO-STICK SETMedical Components, Inc.DYB2026-02-19
30884908188463MICRO-STICK SETMedical Components, Inc.DYB2026-02-19
50884908188474MICRO-STICK SETMedical Components, Inc.DYB2026-02-19
50884908188481MICRO-STICK SETMedical Components, Inc.DYB2026-02-19
20801902225362ARROWTELEFLEX INCORPORATEDDYB2026-02-17
20884450119475Prelude EASE™Merit Medical Systems, Inc.DYB2026-02-14
50382903829120Insyte AutoguardBECTON, DICKINSON AND COMPANYDYB2026-02-13
30382903829249Insyte AutoguardBECTON, DICKINSON AND COMPANYDYB2026-02-13
50382903829472Insyte AutoguardBECTON, DICKINSON AND COMPANYDYB2026-02-13
50382903829540Insyte AutoguardBECTON, DICKINSON AND COMPANYDYB2026-02-13
20801902225133ARROWTELEFLEX INCORPORATEDDYB2026-02-13