FDA.reportPublic FDA data

Bio Protech

Primary DI
00817120020746
Brand
Bio Protech
Company
BIO PROTECH USA, INC.
Model
P9552F
Device description
P9552F - Grounding Pads, Corded, Adult, Foam, Dual Pad, Horizontal (1pc per pouch, 25pc per box, 8box per case)
Published
2017-06-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

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
K073360000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K073360000PROPLATEBio Protech, Inc.2007-12-19GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10817120020002PackageGS1200In Commercial Distribution
10817120020743PackageGS1100In Commercial Distribution
00817120020746PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081712002000210817120020002
1081712002074310817120020743
00817120020746008171200207468171200207460817120020746

GMDN Terms#

Term, Definition table
TermDefinition
Electrosurgical return electrode, single-useA 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 will typically be designed with permanently attached leads. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
909-464-1464bioprotechusa@gmail.com

Regulatory Flags#

DUNS number
789127011
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817120020609BLUE HAND03RD XTFA2026-07-07
00817120021460BLUE HAND1515SQ XTFO2026-07-07
00817120021477BLUE HAND1.5RD XTFO2026-07-07
00817120021484BLUE HAND02RD XTFO2026-07-07
00817120021491BLUE HAND22SQ XTFO2026-07-07
00817120021507BLUE HAND24RT XTFO2026-07-07
00817120021514BLUE HAND03RD XTFO2026-07-07
00817120020067BLUE HAND1515SQ XTFA2026-07-07
00817120020050Bio Protech48482026-05-07
00817120020043Bio Protech48482016-06-15
00817120020340Bio Protech4848WCBZGN(NST)2016-06-21
00817120021088Bio ProtechSG15R (Lifelines)2017-08-09
00817120021095Bio ProtechSG15G (Lifelines)2017-08-09
00817120021101Bio ProtechNCS-1334 (Lifelines)2017-08-09
00817120021118Bio ProtechNCS-SG15 (Lifelines)2017-08-09
00817120021125Bio ProtechMF2409 (Lifelines)2017-08-09
00817120020005Bio Protech MaxTens 1k 2016-06-15
00817120020074Bio ProtechMaxEMS 1k2016-06-16
00817120020081Bio Protech MaxEMS 2k2016-06-17
00817120020562Bio Protech MaxTens 1k Unit2016-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506092930ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-22
00198506092947ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-22
00198506093234ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-22
04250418748346Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGEI2026-07-21
04250418753722Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGEI2026-07-21
08800020100481POTENZA TipJeisys Medical Inc.GEI2026-07-21
08800020101754POTENZA HandpieceJeisys Medical Inc.GEI2026-07-21
08800020101761POTENZA HandpieceJeisys Medical Inc.GEI2026-07-21
08800020101778POTENZA HandpieceJeisys Medical Inc.GEI2026-07-21
08800020110541INTRAcel PremiumJeisys Medical Inc.GEI2026-07-21
00190776402143MillenniumAvalign Technologies, Inc.GEI2026-07-19
00198506092756ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-17
00198506092923ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-17
B382SD89239290Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89509290Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89529290Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89759150Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89819320Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89839280Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89839290Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89914450Surgical DirectSurgical Direct, Inc.GEI2026-07-17
00190776398484MillenniumAvalign Technologies, Inc.GEI2026-07-16
08800020100276INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100283INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100306INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100313INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100320INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100337INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020104984DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020104991DENSITY TipJeisys Medical Inc.GEI2026-07-16