FDA.reportPublic FDA data

MEDLINE INDUSTRIES, INC.

Primary DI
10080196775972
Brand
MEDLINE INDUSTRIES, INC.
Company
MEDLINE INDUSTRIES, INC.
Model
ESRK3000
Catalog number
ESRK3000
Device description
PENCIL,CAUTERY,ROCKER,STERILE,LF,SS
Published
2021-01-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30080196775976PackageGS125In Commercial Distribution
40080196775973PackageGS150In Commercial Distribution
10080196775972PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3008019677597630080196775976
4008019677597340080196775973
1008019677597210080196775972

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic electrosurgical handpiece/electrode, bipolar, single-useA sterile electrosurgical device which consists of a handpiece with mechanical and/or electrical controls, and a bipolar electrode intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery, and may in addition be intended for open surgery; it is not intended for focal percutaneous ablation. It includes a long thin electrode connected to the handpiece, and may include a lumen for suction/irrigation; it is available in a variety of forms (e.g., forceps, rigid probe with controls). This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags#

DUNS number
025460908
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10080196031764MEDLINEDYND20125DYND201252026-07-13
10197344175963MEDLINEESS7012EPESS7012EP2026-07-13
10197344175970MEDLINEESS7022EPESS7022EP2026-07-13
10197344175987MEDLINEESS7044EPESS7044EP2026-07-13
10197344176007MEDLINEESS9022EPESS9022EP2026-07-13
10197344176014MEDLINEESS9045EPESS9045EP2026-07-13
10197344176021MEDLINEESS9048EPESS9048EP2026-07-13
10197344176038MEDLINEESS9066EPESS9066EP2026-07-13
10197344214723MEDLINEHCSLADYBUGSOLHCSLADYBUGSOL2026-07-13
20193489108214MEDLINEMDTZ1017073CAMDTZ1017073CA2026-07-13
20197344219435MEDLINEMDT2168056XGVMDT2168056XGV2026-07-13
20888277636559MEDLINEMDTZ1017073ABMDTZ1017073AB2026-07-13
10080196316809MedlineMSC8722EPMSC8722EP2023-08-15
10080196316816MedlineMSC8744EPMSC8744EP2023-08-15
10193489081053MedlineMSC8422MSC84222023-08-15
10193489081060MedlineMSC8444MSC84442023-08-15
10197344039821MEDLINEHNY19075HNY190752024-10-11
10884389122952MedlineMSC871X8EPMSC871X8EP2023-08-15
10884389155448MedlineMSC8488MSC84882023-08-15
10888277720749MedlineMSC8722EPFMSC8722EPF2023-08-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00848657078399AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GEI2026-07-10
00848657078405AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GEI2026-07-10
03665415002710Bipolar electrode UNIV / THIN, extra length (round ; Fr26)LAMIDEY NOURY MEDICALGEI2026-07-10
07613327666878N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.GEI2026-06-25
07613327666885N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.GEI2026-06-25
07613327666892N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.GEI2026-06-25
07613327666908N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.GEI2026-06-25
07613327666915N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.GEI2026-06-25
07613327666922N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.GEI2026-06-25
00190776421755MillenniumAvalign Technologies, Inc.GEI2026-06-24
00813527028590E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028613E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028637E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028651E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028675E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028699E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028712E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028736E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028750E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028774E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028798E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028811E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028835E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028859E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028873E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028897E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028910E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527029153E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
B112S03086NSU200STINGRAY SURGICAL PRODUCTSSTINGRAY SURGICAL PRODUCTS L.L.C.GEI2026-06-10
00198506091292ELMED INCORPORATEDELMED INCORPORATEDGEI2026-06-09