FDA.reportPublic FDA data

MEDLINE INDUSTRIES, INC.

Primary DI
40198459398088
Brand
MEDLINE INDUSTRIES, INC.
Company
MEDLINE INDUSTRIES, INC.
Model
DYNJZ150597
Catalog number
DYNJZ150597
Device description
TIP CAUTERY 6.5IN PTFE MOD
Published
2025-07-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K081791000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K081791000E-Z CLEAN ELECTROSURGICAL ELECTRODEMegadyne Medical Products, Inc.2008-10-21GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40198459398088PackageGS112In Commercial Distribution
10198459398087PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4019845939808840198459398088
1019845939808710198459398087

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, non-medicated, single-useA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
025460908
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
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
10653160393894MEDLINEEBSI1883EBSI18832026-10-15
10653160394310MEDLINEEBSI1365BEBSI1365B2026-10-15
10653160394327MEDLINEDYNDV2345BDYNDV2345B2026-10-15
10653160394334MEDLINEDYNDV2720ADYNDV2720A2026-10-15
10653160394426MEDLINEEBSI1339CEBSI1339C2026-10-15
10653160394433MEDLINEEBSI1364BEBSI1364B2026-10-15
10653160394457MEDLINEEBSI1118BEBSI1118B2026-10-15
10653160394488MEDLINEDYNDV2796DYNDV27962026-10-15
10653160394556MEDLINEDYNDV2517ADYNDV2517A2026-10-15
10653160394587MEDLINEDYNDC3625DYNDC36252026-10-15
10653160394617MEDLINEDYNDH2389DYNDH23892026-10-15
10653160394662MEDLINEDYNDC3628DYNDC36282026-10-15
10653160394679MEDLINEDYNDC3627DYNDC36272026-10-15
10653160394693MEDLINEEBSI1567BEBSI1567B2026-10-15
10653160394877MEDLINEDYNDV2421ADYNDV2421A2026-10-15
10653160394907MEDLINEDYNDC3622ADYNDC3622A2026-10-15
10653160394969MEDLINEEBSI1147AEBSI1147A2026-10-15
10653160394983MEDLINEDYNDC3619DYNDC36192026-10-15
10653160395027MEDLINEEBSI1148AEBSI1148A2026-10-15
10653160395072MEDLINEDYNDV2812DYNDV28122026-10-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10381780533276Codman®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEI2026-10-15
10381780533283Codman®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEI2026-10-15
00190776435028MillenniumAvalign Technologies, Inc.GEI2026-10-14
00190776434878MillenniumAvalign Technologies, Inc.GEI2026-10-13
08800142924491OsteoBlate™RF Medical Co.,Ltd.GEI2026-10-13
00190776434656MillenniumAvalign Technologies, Inc.GEI2026-10-12
B108890APMMUS00EMFACE controllerBTL INDUSTRIES LIMITEDGEI2026-10-12
B108890APSMUS00EXION Face applicatorBTL INDUSTRIES LIMITEDGEI2026-10-12
00190776434083MillenniumAvalign Technologies, Inc.GEI2026-10-09
00190776434199MillenniumAvalign Technologies, Inc.GEI2026-10-09
B382SD030861101530Surgical DirectSurgical Direct, Inc.GEI2026-10-09
00190776436186MillenniumAvalign Technologies, Inc.GEI2026-10-08
00190776436544MilleniumAvalign Technologies, Inc.GEI2026-10-08
00190776436599MilleniumAvalign Technologies, Inc.GEI2026-10-08
00840096215380Disposable Bipolar Forceps, 8", 1.5mm Straight TipsKATALYST SURGICAL LLCGEI2026-10-08
00848657078504AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GEI2026-10-08
00848657078511AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GEI2026-10-08
00848657078528AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GEI2026-10-08
00848657083805AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GEI2026-10-08
00848657083904AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GEI2026-10-08
00840096215335Disposable Bipolar Forceps, 7", 0.5mm Straight TipsKATALYST SURGICAL LLCGEI2026-10-07
00840096215342Disposable Bipolar Forceps, 7", 1.0mm Straight TipsKATALYST SURGICAL LLCGEI2026-10-07
00840096215359Disposable Bipolar Forceps, 7", 1.5mm Straight TipsKATALYST SURGICAL LLCGEI2026-10-07
00840096215366Disposable Bipolar Forceps, 8", 0.5mm Straight TipsKATALYST SURGICAL LLCGEI2026-10-07
00840096215373Disposable Bipolar Forceps, 8", 1.0mm Straight TipsKATALYST SURGICAL LLCGEI2026-10-07
00840096215397Disposable Bipolar Forceps, 9", 0.5mm Straight TipsKATALYST SURGICAL LLCGEI2026-10-07
00840096215403Disposable Bipolar Forceps, 9", 1.0mm Straight TipsKATALYST SURGICAL LLCGEI2026-10-07
00840096215410Disposable Bipolar Forceps, 9", 1.5mm Straight TipsKATALYST SURGICAL LLCGEI2026-10-07
00190776434328MillenniumAvalign Technologies, Inc.GEI2026-10-06
B382SD134188100Surgical DirectSurgical Direct, Inc.GEI2026-10-06