FDA.reportPublic FDA data

STERIS

Primary DI
00817688023616
Brand
STERIS
Company
I.C. MEDICAL, INC.
Model
SSESHR05
Catalog number
SSESHR05
Device description
ICM-000-0652 STERIS ESU Shroud, Short Tip, 9 Foot Tube & Universal Connector, Sterile
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
Sterile
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
00817688023623PackageGS125Not in Commercial Distribution
00817688023616PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817688023623008176880236238176880236230817688023623
00817688023616008176880236168176880236160817688023616

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

Contacts#

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

Regulatory Flags#

DUNS number
616182895
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
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
00190776436827MillenniumAvalign Technologies, Inc.GCJ2026-10-22
B382SD772553050Surgical DirectSurgical Direct, Inc.GCJ2026-10-22
00190776435677MillenniumAvalign Technologies, Inc.GCJ2026-10-21
00190776435684MillenniumAvalign Technologies, Inc.GCJ2026-10-21
00190776435493MillenniumAvalign Technologies, Inc.GCJ2026-10-20
00190776435547MillenniumAvalign Technologies, Inc.GCJ2026-10-20
00190776435295MillenniumAvalign Technologies, Inc.GCJ2026-10-19
00190776435455MillenniumAvalign Technologies, Inc.GCJ2026-10-19
B354OSCVORTH80Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
B354OSCVORTH81Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
B354OSCVORTH82Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
B354OSCVORTH83Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
B354OSCVORTH84Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
B354OSCVORTH85Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
B354OSCVORTH89Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19
04548736175013OLYMPUSSONY CORPORATIONGCJ2026-10-15
04548736175068OLYMPUSSONY CORPORATIONGCJ2026-10-15
04548736175112OLYMPUSSONY CORPORATIONGCJ2026-10-15
00190776434922MillenniumAvalign Technologies, Inc.GCJ2026-10-14
00190776434823MillenniumAvalign Technologies, Inc.GCJ2026-10-13
00190776434854MillenniumAvalign Technologies, Inc.GCJ2026-10-13
B382SD56300680Surgical DirectSurgical Direct, Inc.GCJ2026-10-13
B382SD563006820Surgical DirectSurgical Direct, Inc.GCJ2026-10-13
00190776434250MillenniumAvalign Technologies, Inc.GCJ2026-10-09
00848657078481AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GCJ2026-10-08
00848657078498AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GCJ2026-10-08
00190776433697MillenniumAvalign Technologies, Inc.GCJ2026-10-07
00190776433703MillenniumAvalign Technologies, Inc.GCJ2026-10-07
00190776433710MillenniumAvalign Technologies, Inc.GCJ2026-10-07
00190776433727MillenniumAvalign Technologies, Inc.GCJ2026-10-07