FDA.reportPublic FDA data

STERIS

Primary DI
00817688023562
Brand
STERIS
Company
I.C. MEDICAL, INC.
Model
SSESHR02
Catalog number
SSESHR02
Device description
ICM-000-0648 STERIS ESU Shroud, Short Tip, & 9 Foot Tube, Non-Sterile, Bulk
Published
2021-10-19
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GCJLaparoscope, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817688023562PrimaryGS10
00817688023555Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817688023562008176880235628176880235620817688023562
00817688023555008176880235558176880235550817688023555

GMDN Terms#

Term, Definition table
TermDefinition
Surgical plume evacuation system tubeA long, hollow cylinder which, as part of a surgical plume evacuation system, is intended to be used to capture, conduct, and exhaust the plume of smoke generated during open surgical procedures in which there is tissue ablation (e.g., laser surgery, electrocautery, electrosurgical diathermy device). This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity30 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Storage Environment Temperature0 Degrees Fahrenheit140 Degrees Fahrenheit

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
623-780-0700inquiry@icmedical.com

Regulatory Flags#

DUNS number
616182895
Device count
25
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817688022992STERISSSEFIL01SSEFIL012021-10-19
00817688023043STERISSSEPEN02SSEPEN022021-10-19
00817688023142STERISSSEPEN07SSEPEN072021-10-19
00817688023289STERISSSEPET02SSEPET022021-10-19
00817688023364STERISSSEPET06SSEPET062021-10-19
00817688023531STERISSSESHR01SSESHR012021-10-19
00817688023630STERISSSETUB01SSETUB012021-10-19
00817688023708STERISSSEPEN14SSEPEN142022-05-11
00817688022978STERISSSECAPPLSSSECAPPLS2021-10-19
00817688022985STERISSSECAPREGSSECAPREG2021-10-19
00817688023012STERISSSEFIL02SSEFIL022021-10-19
00817688023500STERISSSESEN01SSESEN012021-10-19
00817688023524STERISSSESEN03SSESEN032021-10-19
00817688023029STERISSSEPEN01SSEPEN012021-10-19
00817688023074STERISSSEPEN03SSEPEN032021-10-19
00817688023081STERISSSEPEN04SSEPEN042021-10-19
00817688023104STERISSSEPEN05SSEPEN052021-10-19
00817688023128STERISSSEPEN06SSEPEN062021-10-19
00817688023173STERISSSEPEN08SSEPEN082021-10-19
00817688023197STERISSSEPEN09SSEPEN092021-10-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995268312Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268329Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268336Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268343Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268350Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268374Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268381Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268398Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268404Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268411Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268428Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268435Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268442Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268459Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268466Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268473Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268480Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268497Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268503Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995269517Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995269531Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995269548Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995269555Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995269562Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995269579Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995269593Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
04995047072416CuratOREIZO CORPORATIONGCJ2026-09-25
00190776432348MillenniumAvalign Technologies, Inc.GCJ2026-09-24
00190776432386MillenniumAvalign Technologies, Inc.GCJ2026-09-24
00190776432416MillenniumAvalign Technologies, Inc.GCJ2026-09-24