FDA.report

GLIDESHEATH SLENDER

Primary DI
30389701011982
Brand
GLIDESHEATH SLENDER
Company
TERUMO MEDICAL CORPORATION
Model
60-1065
Catalog number
60-1065
Device description
GLIDESHEATH SLENDER Access Kit
Published
2018-05-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
DYBINTRODUCER, CATHETER

Product Code Classifications

CodeDeviceSpecialtyClass
DYBIntroducer, CatheterCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
30389701011982PackageGS15In Commercial Distribution
50389701011986PackageGS110In Commercial Distribution
00389701011981PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
3038970101198230389701011982
5038970101198650389701011986
00389701011981003897010119813897010119810389701011981

GMDN Terms

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

TypeValueUnit
Catheter Gauge6French
Device Size Text, specify0
Device Size Text, specify0
Length10Centimeter

Storage And Handling

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

Sterilization Methods

Method

Contacts

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
true
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
false
Sterilization required before use
false

Other Devices From This Company

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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

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