FDA.reportPublic FDA data

LEEP System 1000® Workstation

Primary DI
00888937014433
Brand
LEEP System 1000® Workstation
Company
Coopersurgical, Inc.
Model
KH1000
Device description
LEEP System 1000® Workstation (110 VAC)
Published
2016-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

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

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888937014433PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888937014433008889370144338889370144330888937014433

GMDN Terms#

Term, Definition table
TermDefinition
Electrosurgical systemAn assembly of devices intended to generate, and apply radio-frequency (RF) alternating current to soft tissues for cutting and coagulation during an endoscopic or open surgical procedure; it is not dedicated to focal ablation of specific tissues (i.e., not a radio-frequency ablation system). The assembly includes a mains electricity-powered (AC-powered) RF generator with monitoring functions/controls, connection cables, a handpiece, and electrodes to apply the energy to the surgical site. Tissue resistance to the electrical current creates the heat as the current travels through the body between electrodes; it is not intended for argon-enhanced electrosurgery.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
801895244
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
60888937029798ORIGIO Gradient 90 w/o Gentamicin 84905060D2026-03-12
00888937028331ORIGIO Sequential Blast83050010M2026-02-05
00888937028348ORIGIO Sequential Blast83050060M2026-02-05
00888937028355ORIGIO Sequential Blast83060010M2026-02-05
00888937028386ORIGIO Sequential Cleav83030010M2026-02-05
00888937028393ORIGIO Sequential Cleav83030060M2026-02-05
00888937028409ORIGIO Sequential Cleav83040010M2026-02-05
00888937028416ORIGIO Sequential Cleav83040060M2026-02-05
00888937028430ORIGIO Sequential Fert83010010M2026-02-05
00888937028447ORIGIO Sequential Fert83010060M2026-02-05
00888937028454ORIGIO Sequential Fert83020010M2026-02-05
00888937028461ORIGIO Sequential Fert83020060M2026-02-05
00888937028607SynVitro Flush15840125M2026-02-05
00888937028959Origio Handling83100060M83102026-02-05
00888937028966Origio Handling83100125M83102026-02-05
00888937028973Origio Handling83110060M83112026-02-05
00888937028980Origio Handling83110125M83112026-02-05
00888937029116SAGE 1-Step67010010M2026-02-05
00888937029123SAGE 1-Step67010060M2026-02-05
60888937029330ORIGIO Sperm Wash84050060M2026-02-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00887482177044BovieSYMMETRY SURGICAL INC.HGI2024-08-28
00887482177082BovieSYMMETRY SURGICAL INC.HGI2024-08-28
00887482141656BovieSYMMETRY SURGICAL INC.HGI2024-08-28
00887482177075BovieSYMMETRY SURGICAL INC.HGI2024-08-28
00887482177570BovieSYMMETRY SURGICAL INC.HGI2024-08-28
00887482177594BovieSYMMETRY SURGICAL INC.HGI2024-08-28
00887482177723BovieSYMMETRY SURGICAL INC.HGI2024-08-27
00887482177754BovieSYMMETRY SURGICAL INC.HGI2024-08-27
00887482177792BovieSYMMETRY SURGICAL INC.HGI2024-08-27
00887482177839BovieSYMMETRY SURGICAL INC.HGI2024-08-27
00887482177877BovieSYMMETRY SURGICAL INC.HGI2024-08-27
00887482177914BovieSYMMETRY SURGICAL INC.HGI2024-08-27
10887482177928BovieSYMMETRY SURGICAL INC.HGI2024-08-27
00887482177952BovieSYMMETRY SURGICAL INC.HGI2024-08-27
00887482177976BovieSYMMETRY SURGICAL INC.HGI2024-08-27
00887482177990BovieSYMMETRY SURGICAL INC.HGI2024-08-27
00887482178010BovieSYMMETRY SURGICAL INC.HGI2024-08-27
00887482178034BovieSYMMETRY SURGICAL INC.HGI2024-08-27
00887482178058BovieSYMMETRY SURGICAL INC.HGI2024-08-27
00887482178072BovieSYMMETRY SURGICAL INC.HGI2024-08-27
00887482178133BovieSYMMETRY SURGICAL INC.HGI2024-08-27
00887482178171BovieSYMMETRY SURGICAL INC.HGI2024-08-27
00887482178218BovieSYMMETRY SURGICAL INC.HGI2024-08-27
00887482178232BovieSYMMETRY SURGICAL INC.HGI2024-08-27
00887482178256BovieSYMMETRY SURGICAL INC.HGI2024-08-27
00887482178270BovieSYMMETRY SURGICAL INC.HGI2024-08-27
00887482178294BovieSYMMETRY SURGICAL INC.HGI2024-08-27
00887482178317BovieSYMMETRY SURGICAL INC.HGI2024-08-27
00887482178331BovieSYMMETRY SURGICAL INC.HGI2024-08-27
00887482178355BovieSYMMETRY SURGICAL INC.HGI2024-08-27