FDA.reportPublic FDA data

Snowden-Pencer

Primary DI
10885403159183
Brand
Snowden-Pencer
Company
STERIS CORPORATION
Model
SP90-6335
Catalog number
SP906335
Device description
DIAMOND-LINE DISSECTOR FENESTRATED, 10MM JAW 5MM, 36CM, ESU PAT PENDING
Published
2018-03-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K930666000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K930666000REUSABLE LAPAROSCOPIC INSTRUMENTS W/ ELECTROCAUTERYSnowden-Pencer1994-05-19GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10885403159183PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088540315918310885403159183

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic electrosurgical handpiece/electrode, monopolar, reusableAn electrosurgical device which consists of a handpiece with mechanical and/or electrical controls, and a monopolar electrode, intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery. It includes a long thin electrode connected to the handpiece, and may include a lumen for suction/irrigation; it is available in a variety of forms (e.g., forceps or snare with ring handles, rigid probe with controls) and requires a patient contact return electrode to complete the circuit. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)323-9088gmb-MedSpec-CustService@carefusion.com
+1(800)548-4873xx@xx.xx

Regulatory Flags#

DUNS number
021599373
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10885403018947V. MuellerCD1-4BCD14B2017-11-17
10885403018954V. MuellerCD1-4CCD14C2017-11-17
10885403018985V. MuellerCD1-5BCD15B2017-11-17
10885403018992V. MuellerCD1-5CCD15C2017-11-17
10885403019029V. MuellerCD1-6BCD16B2017-11-17
10885403019036V. MuellerCD1-6CCD16C2018-01-22
10885403019074V. MuellerCD1-7CDLCD17CDL2018-01-22
10885403125676V. MuellerCD1-8BDLCD18BDL2018-01-22
10885403186141V. MuellerDINCD1-5BDINCD15B2018-03-15
10885403186158V. MuellerDINCD1-5CDINCD15C2018-03-15
10885403186165V. MuellerDINCD1-6BDINCD16B2018-03-15
10885403186172V. MuellerDINCD1-6CDINCD16C2018-08-13
10885403193798V. MuellerCD1-4B-GOLDCD14BGOLD2017-11-17
10885403193804V. MuellerCD1-4B-PURPLECD14BPURPLE2017-11-17
10885403193811V. MuellerCD1-4B-BLUECD14BBLUE2017-11-17
10885403193828V. MuellerCD1-4B-GREENCD14BGREEN2017-11-17
10885403193835V. MuellerCD1-4B-REDCD14BRED2017-11-17
10885403193842V. MuellerCD1-4B-BLACKCD14BBLACK2017-11-17
10885403193859V. MuellerCD1-5B-GOLDCD15BGOLD2017-11-17
10885403193866V. MuellerCD1-5B-PURPLECD15BPURPLE2017-11-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776426675MillenniumAvalign Technologies, Inc.GEI2026-08-19
00190776426729MillenniumAvalign Technologies, Inc.GEI2026-08-19
00190776426781MillenniumAvalign Technologies, Inc.GEI2026-08-19
00841019123713KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-08-19
00841019123720KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-08-19
00841019123737KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-08-19
00841019123744KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-08-19
00841019124154KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-08-19
00190776414733MillenniumAvalign Technologies, Inc.GEI2026-08-18
00190776415310MillenniumAvalign Technologies, Inc.GEI2026-08-18
00190776425890MillenniumAvalign Technologies, Inc.GEI2026-08-18
00190776425913MillenniumAvalign Technologies, Inc.GEI2026-08-18
00190776425920MillenniumAvalign Technologies, Inc.GEI2026-08-18
00190776425937MillenniumAvalign Technologies, Inc.GEI2026-08-18
00190776425944MillenniumAvalign Technologies, Inc.GEI2026-08-18
00190776425951MillenniumAvalign Technologies, Inc.GEI2026-08-18
00190776426354MillenniumAvalign Technologies, Inc.GEI2026-08-18
00190776426385MillenniumAvalign Technologies, Inc.GEI2026-08-18
00190776426422MillenniumAvalign Technologies, Inc.GEI2026-08-18
00190776426545MillenniumAvalign Technologies, Inc.GEI2026-08-18
00190776426552MillenniumAvalign Technologies, Inc.GEI2026-08-18
00198506093982ELMED INCORPORATEDELMED INCORPORATEDGEI2026-08-18
00841019123898KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-08-18
00840113234356BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-08-17
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