FDA.reportPublic FDA data

Henry Schein

Primary DI
10304040071035
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
5700888
Catalog number
5700888
Device description
H-Type Sharp Tip Disposable
Published
2019-10-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10304040071035PrimaryGS10
00304040071038Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1030404007103510304040071035
00304040071038003040400710383040400710380304040071038

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
012430880
Device count
50
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
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
00304040195437Henry Schein570582457058242026-03-17
00304040195444Henry Schein570582557058252026-03-17
00304040195420Henry Schein570582357058232026-03-13
00304040187463Zirlux920004692000462026-02-04
00304040187470Zirlux920004792000472026-02-04
00304040187487Zirlux920004892000482026-02-04
00304040187517Zirlux920005192000512026-02-04
00304040187524Zirlux920005292000522026-02-04
00304040187531Zirlux920005392000532026-02-04
00304040187548Zirlux920005492000542026-02-04
00304040187555Zirlux920005592000552026-02-04
00304040187562Zirlux920005692000562026-02-04
00304040187579Zirlux920005792000572026-02-04
00304040187586Zirlux920005892000582026-02-04
00304040187593Zirlux920005992000592026-02-04
00304040187616Zirlux920006192000612026-02-04
00304040187623Zirlux920006292000622026-02-04
00304040187647Zirlux920006392000632026-02-04
00304040187654Zirlux920006492000642026-02-04
00304040187661Zirlux920006592000652026-02-04

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