FDA.reportPublic FDA data

MEDLINE

Primary DI
10193489198539
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
ESE1651
Catalog number
ESE1651
Device description
4.5CM MICROSURGICAL NDL TNG ST
Published
2020-10-27
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

Contact Domains#

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
K931338000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K93133800016 ELECTRODES (BLADE, BALL, NEEDLE & LOOP)Aaron Medical Industries1994-02-16HGI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20193489198536PackageGS110In Commercial Distribution
10193489198539PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2019348919853620193489198536
1019348919853910193489198539

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic electrosurgical electrode, bipolar, single-useAn invasive, distal component of an electrosurgical assembly intended to deliver electrosurgical current in a bipolar configuration (i.e., without a return electrode) to tissues for cutting/coagulation/ablation during endoscopic (e.g., laparoscopic, arthroscopic) surgery. It is available in a variety of forms (e.g., exchangeable electrode for electrosurgical forceps, rigid electrode, flexible endoscopic probe) which may include a lumen for suction/irrigation. It does not include a handpiece or housing and has no electrical or mechanical controls (e.g., does not include controlling ring-handles). This is a single-use device intended to be used in a sterile condition.

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463CUSTOMERSERVICE@MEDLINE.COM

Regulatory Flags#

DUNS number
025460908
Device count
1
DM exempt
true
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
10193489135909MEDLINEDYNJP2228SGDYNJP2228SG2026-07-17
10197344112722MEDLINESSBCS23GTSSBCS23GT2026-07-17
10197344157174MEDLINESNAPSECUREPSNAPSECUREP2026-07-17
10197344169450MEDLINEMSCSRG9736MSCSRG97362026-07-17
10197344205141MEDLINEMSC608ASXLMSC608ASXL2026-07-17
10197344216116MEDLINESSBCS21GSSBCS21G2026-07-17
10197344216130MEDLINESSBCS21GTSSBCS21GT2026-07-17
10197344216147MEDLINESSBCS23GSSBCS23G2026-07-17
10197344216154MEDLINESSBCS23GLSSBCS23GL2026-07-17
10197344216161MEDLINESSBCS25GSSBCS25G2026-07-17
10197344216178MEDLINESSBCS25GLSSBCS25GL2026-07-17
10197344216185MEDLINESSBCS25GTSSBCS25GT2026-07-17
10884389362020MEDLINEDYNJSMD01DYNJSMD012026-07-17
10888277407954MEDLINEOR87VOR87V2026-07-17
20193489029939MEDLINEMDTZ1020872GHMDTZ1020872GH2026-07-17
20193489029953MEDLINEMDTZ1020872GJMDTZ1020872GJ2026-07-17
20197344033925MEDLINEMLABDISH35MLABDISH352026-07-17
20197344033956MEDLINEMLABDISH65MLABDISH652026-07-17
20197344219428MEDLINEMDT2168054XGVMDT2168054XGV2026-07-17
20197344219442MEDLINEMDT2168104GVMDT2168104GV2026-07-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10887482196646ValleylabASPEN SURGICAL PRODUCTS, INC.HGI2025-10-08
10887482196653ValleylabASPEN SURGICAL PRODUCTS, INC.HGI2025-10-08
10887482196707ValleylabASPEN SURGICAL PRODUCTS, INC.HGI2025-10-08
10887482196714ValleylabASPEN SURGICAL PRODUCTS, INC.HGI2025-10-08
10887482196721ValleylabASPEN SURGICAL PRODUCTS, INC.HGI2025-10-08
10887482196738ValleylabASPEN SURGICAL PRODUCTS, INC.HGI2025-10-08
10887482196745ValleylabASPEN SURGICAL PRODUCTS, INC.HGI2025-10-08
10887482196752ValleylabASPEN SURGICAL PRODUCTS, INC.HGI2025-10-08
10887482177065BovieASPEN SURGICAL PRODUCTS, INC.HGI2024-08-28
10887482177560BovieASPEN SURGICAL PRODUCTS, INC.HGI2024-08-28
10887482177584BovieASPEN SURGICAL PRODUCTS, INC.HGI2024-08-28
10887482177713BovieASPEN SURGICAL PRODUCTS, INC.HGI2024-08-27
10887482177737BovieASPEN SURGICAL PRODUCTS, INC.HGI2024-08-27
10887482177782BovieASPEN SURGICAL PRODUCTS, INC.HGI2024-08-27
10887482177829BovieASPEN SURGICAL PRODUCTS, INC.HGI2024-08-27
10887482177867BovieASPEN SURGICAL PRODUCTS, INC.HGI2024-08-27
10887482177904BovieASPEN SURGICAL PRODUCTS, INC.HGI2024-08-27
10887482177942BovieASPEN SURGICAL PRODUCTS, INC.HGI2024-08-27
10887482177966BovieASPEN SURGICAL PRODUCTS, INC.HGI2024-08-27
10887482177980BovieASPEN SURGICAL PRODUCTS, INC.HGI2024-08-27
10887482178000BovieASPEN SURGICAL PRODUCTS, INC.HGI2024-08-27
10887482178024BovieASPEN SURGICAL PRODUCTS, INC.HGI2024-08-27
10887482178048BovieASPEN SURGICAL PRODUCTS, INC.HGI2024-08-27
10887482178062BovieASPEN SURGICAL PRODUCTS, INC.HGI2024-08-27
10887482178123BovieASPEN SURGICAL PRODUCTS, INC.HGI2024-08-27
10887482178161BovieASPEN SURGICAL PRODUCTS, INC.HGI2024-08-27
10887482178208BovieASPEN SURGICAL PRODUCTS, INC.HGI2024-08-27
10887482178222BovieASPEN SURGICAL PRODUCTS, INC.HGI2024-08-27
10887482178246BovieASPEN SURGICAL PRODUCTS, INC.HGI2024-08-27
10887482178260BovieASPEN SURGICAL PRODUCTS, INC.HGI2024-08-27