FDA.reportPublic FDA data

LEEP Radius Electrode

Primary DI
00888937010787
Brand
LEEP Radius Electrode
Company
Coopersurgical, Inc.
Model
R1505
Device description
LEEP Radius Electrode;1.5cm x 0.5cm; 12cm Shaft
Published
2016-08-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HGIElectrocautery, Gynecologic (And Accessories)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HGIElectrocautery, Gynecologic (And Accessories)Obstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K905747000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K905747000LEEP SYSTEM 6000 ELECTROSURGICAL UNIT AND ACCESSORCoopervision Surgical1991-09-17HGI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20888937010781PackageGS15In Commercial Distribution
00888937010787PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2088893701078120888937010781
00888937010787008889370107878889370107870888937010787

GMDN Terms#

Term, Definition table
TermDefinition
Open-surgery electrosurgical electrode, monopolar, single-useAn invasive, monopolar, electrical conductor intended to be attached to an appropriate handle/handpiece (not included) to deliver electrosurgical current directly to tissues for cutting/coagulation during an open surgical procedure. It may be available in a variety of forms (e.g., blade, ball, loop, needle, spatula) and requires a patient contact return electrode to complete the circuit. This is a single-use device intended to be used in a sterile condition.

Regulatory Flags#

DUNS number
801895244
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888937027327ER-SpecC0203002026-08-05
00888937027334ER-SpecC0203102026-08-05
00888937027341ER-SpecC0203202026-08-05
00888937027358HER-SpecC0206002026-08-05
00888937027365HER-SpecC0206102026-08-05
00888937027372HER-SpecC0206202026-08-05
00888937027389OfficeSPECC0200012026-08-06
00888937027396HER-SpecC0205002026-08-06
00888937027402HER-SpecC0205102026-08-06
00888937027419HER-SpecC0205202026-08-06
00888937027426ER-SPECC020100-12026-08-06
00888937027433ER-SPECC020110-12026-08-06
00888937027440ER-SpecC020120-12026-08-06
00888937027457ER-SpecC020130-12026-08-06
00888937027464ER-SpecC020140-12026-08-06
00888937027594AnoSPECC0601002026-08-05
00888937027600AnoSPECC0601102026-08-05
00888937027617AnoSPECC0601202026-08-05
00888937032833LifeGlobal® Coda®Incubator UnitGCIU-010-M2026-08-03
00888937032840LifeGlobal® Coda®Filter for Incubator UnitGCIF-001-M2026-08-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10840113236838BovieASPEN SURGICAL PRODUCTS, INC.HGI2026-09-21
10840113236845BovieASPEN SURGICAL PRODUCTS, INC.HGI2026-09-21
10840113236876BovieASPEN SURGICAL PRODUCTS, INC.HGI2026-09-21
10840113236883BovieASPEN SURGICAL PRODUCTS, INC.HGI2026-09-21
10840113236906BovieASPEN SURGICAL PRODUCTS, INC.HGI2026-09-21
10840113236920BovieASPEN SURGICAL PRODUCTS, INC.HGI2026-09-21
10840113236944BovieASPEN SURGICAL PRODUCTS, INC.HGI2026-09-21
10840113236951BovieASPEN SURGICAL PRODUCTS, INC.HGI2026-09-21
10840113236968BovieASPEN SURGICAL PRODUCTS, INC.HGI2026-09-21
10840113236975BovieASPEN SURGICAL PRODUCTS, INC.HGI2026-09-21
10840113236982BovieASPEN SURGICAL PRODUCTS, INC.HGI2026-09-21
10840113236999BovieASPEN SURGICAL PRODUCTS, INC.HGI2026-09-21
10840113237002BovieASPEN SURGICAL PRODUCTS, INC.HGI2026-09-21
10840113237019BovieASPEN SURGICAL PRODUCTS, INC.HGI2026-09-21
10840113237026BovieASPEN SURGICAL PRODUCTS, INC.HGI2026-09-21
10840113237033BovieASPEN SURGICAL PRODUCTS, INC.HGI2026-09-21
10840113237057BovieASPEN SURGICAL PRODUCTS, INC.HGI2026-09-21
10840113237071BovieASPEN SURGICAL PRODUCTS, INC.HGI2026-09-21
10840113237095BovieASPEN SURGICAL PRODUCTS, INC.HGI2026-09-21
10840113237125BovieASPEN SURGICAL PRODUCTS, INC.HGI2026-09-21
10840113237149BovieASPEN SURGICAL PRODUCTS, INC.HGI2026-09-21
10840113237156BovieASPEN SURGICAL PRODUCTS, INC.HGI2026-09-21
10840113237163BovieASPEN SURGICAL PRODUCTS, INC.HGI2026-09-21
10840113237170BovieASPEN SURGICAL PRODUCTS, INC.HGI2026-09-21
10840113237187BovieASPEN SURGICAL PRODUCTS, INC.HGI2026-09-21
10840113237194BovieASPEN SURGICAL PRODUCTS, INC.HGI2026-09-21
10840113237200BovieASPEN SURGICAL PRODUCTS, INC.HGI2026-09-21
10840113237217BovieASPEN SURGICAL PRODUCTS, INC.HGI2026-09-21