FDA.reportPublic FDA data

STERIS

Primary DI
00817688023289
Brand
STERIS
Company
I.C. MEDICAL, INC.
Model
SSEPET02
Catalog number
SSEPET02
Device description
ICM-000-0628 STERIS Telescopic ESU Pencil, Non-Stick Blade, 10 Foot Tube & Holster, Sterile
Published
2021-10-19
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEIElectrosurgical, Cutting & Coagulation & Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817688023296PackageGS120Not in Commercial Distribution
00817688023289PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817688023296008176880232968176880232960817688023296
00817688023289008176880232898176880232890817688023289

GMDN Terms#

Term, Definition table
TermDefinition
Open-surgery electrosurgical handpiece/electrode, monopolar, single-useA rigid device consisting of combined electrosurgical handpiece and monopolar electrode intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation during an open surgical procedure. It is available in a variety of forms (e.g., pen, pistol-shaped forceps, pincer-shaped forceps, scissors) and may also include irrigation, aspiration, lavage and/or surgical plume (smoke) evacuation features to support its primary electrosurgical function. This is a single-use device intended to be used in a sterile condition.

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
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
00817688023210STERISSSEPEN10SSEPEN102021-10-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10840113237705BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-08-17
10840113237712BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-08-17
00190776424527MillenniumAvalign Technologies, Inc.GEI2026-08-07
00841019123935KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-08-07
00841019123942KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-08-07
07613327548235NeptuneSTRYKER CORPORATIONGEI2026-08-07
08800017100920VIVACE Microneedle Cartridgeshenb Co., Ltd.GEI2026-08-07
00190776408718MillenniumAvalign Technologies, Inc.GEI2026-08-03
00190776422677MillenniumAvalign Technologies, Inc.GEI2026-08-03
00190776422820MillenniumAvalign Technologies, Inc.GEI2026-08-03
B382SD5657815600Surgical DirectSurgical Direct, Inc.GEI2026-08-03
00190776407445MillenniumAvalign Technologies, Inc.GEI2026-07-31
00190776422332MillenniumAvalign Technologies, Inc.GEI2026-07-31
00190776422516MillenniumAvalign Technologies, Inc.GEI2026-07-31
07613327601152OptaBlateSTRYKER CORPORATIONGEI2025-04-17
07613327631883OptaBlateSTRYKER CORPORATIONGEI2025-04-17
00817495024325Standard 64 Sublative iD, (400 Pulse), 10-PkCandela CorporationGEI2023-10-20
07613327524512OptaBlateSTRYKER CORPORATIONGEI2022-10-12
07613327524482OptaBlateSTRYKER CORPORATIONGEI2022-09-23
07613327524505OptaBlateSTRYKER CORPORATIONGEI2022-09-23
10884521782648ValleylabCovidien LPGEI2021-07-12
07613327466225NeptuneSTRYKER CORPORATIONGEI2021-05-07
07613327467642NeptuneSTRYKER CORPORATIONGEI2021-05-07
07613327539363NeptuneSTRYKER CORPORATIONGEI2021-05-07
07613327539370NeptuneSTRYKER CORPORATIONGEI2021-05-07
07613327466331NeptuneSTRYKER CORPORATIONGEI2019-11-18
07613327465655NeptuneSTRYKER CORPORATIONGEI2019-10-16
07613327465662NeptuneSTRYKER CORPORATIONGEI2019-10-16
07613327465679NeptuneSTRYKER CORPORATIONGEI2019-10-16
07613327465686NeptuneSTRYKER CORPORATIONGEI2019-10-16