FDA.reportPublic FDA data

Nova Plus®

Primary DI
50707387563696
Brand
Nova Plus®
Company
3M COMPANY
Model
9160V
Catalog number
9160V
Device description
Electrosurgical Pad with Safety Ring, Split, without Cord, 100 per Case, 9160V
Published
2016-09-24
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
GEIELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K974553000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K9745530003M UNIVERSAL ELECTROSURGICAL PAD, SPLIT (9160) 3M UNIVERSAL ELECTROSURGICAL PAD (9130)3M Healthcare1998-02-03GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50707387563696PrimaryGS10
00707387563691Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5070738756369650707387563696
00707387563691007073875636917073875636910707387563691

GMDN Terms#

Term, Definition table
TermDefinition
Electrosurgical return electrode, single-use, non-sterileA non-sterile dispersive conductor intended to be fastened to a patient and connected to an electrosurgical/radio-frequency ablation system generator, to allow return of electrical current from the patient to the generator during an electrosurgical procedure. It has a large surface area and is fastened to the patient's body typically where the greatest surface area can be covered in closest proximity to the surgical site. It may or may not include a return cable(s). This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)228-39573Mhealthcarecompliance@mmm.com

Regulatory Flags#

DUNS number
830016148
Device count
100
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
088877192573983M™186018602016-08-03
088877192574043M™1860S1860S2016-08-03
506380604335343M™ Aura™1870+1870+2022-06-02
000511312755393M™186018602016-08-03
000511312755463M™1860S1860S2016-08-03
00051131498556VFlex™180518052016-08-03
00051131498563VFlex™1805S1805S2016-08-03
00051131499966Aura™1870+1870+2016-08-03
000680608569683M186018602024-10-25
000680608581223M1860S1860S2024-10-25
006380604309583M™ Aura™1870+1870+2021-08-26
006380604313443M™ Aura™1870+BULK1870+BULK2020-10-22
006380604335463M™ Aura™1870+1870+2022-06-02
007073874194243M™186018602016-08-03
007073874441293M™1860S1860S2016-08-03
300511312759293M™ Vflex™180418042018-02-21
300511312759363M™ Vflex™1804S1804S2018-02-21
007073877752543M™ Bair Hugger™30077300772026-05-15
007073877752613M™ Bair Hugger™31077310772026-05-15
007073877752853M™ Bair Hugger™53777537772026-05-15

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00724995269968Snowden-PencerSTERIS Deutschland GmbHGEI2026-09-25
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10840113237132BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21