FDA.reportPublic FDA data

3M™

Primary DI
50707387580730
Brand
3M™
Company
3M COMPANY
Model
9135-LP
Catalog number
9135-LP
Device description
9135-LP 3M UNIV ELECTROSURGICA L PLATE, STD, CORDED, 40/CASE
Published
2016-09-24
Public version status
Update
Distribution status
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
K974279000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K9742790003M UNIVERSAL ELECTROSURGICAL PAD, WITH CORD (CATALOG NUMBER 9135), 3M UNIVERSAL ELECTROSURGICAL PAD, SPLIT WITH CORD (C)3M Healthcare1998-01-30GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50707387580730PrimaryGS10
00707387580735Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5070738758073050707387580730
00707387580735007073875807357073875807350707387580735

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
40
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

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106058610773823M™ Filtek™4867A14867A12026-05-08
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106058610774053M™ Filtek™4867A34867A32026-05-08
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