FDA.reportPublic FDA data

Integra® Miltex®

Primary DI
10381780152231
Brand
Integra® Miltex®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
35-205
Device description
MIXTER Spreader-Dissector, Monopolar HF Port, Double Action, Non-Ratchet Handle with Rotation Lock
Published
2016-08-03
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HETLAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K043013000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K043013000MILTEX LAPAROSCOPIC INSTRUMENTSMiltex, Inc.2005-03-04HET

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780152231PrimaryGS10
H834352051SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178015223110381780152231

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic electrosurgical handpiece/electrode, monopolar, reusableAn electrosurgical device which consists of a handpiece with mechanical and/or electrical controls, and a monopolar electrode, intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery. 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 or snare with ring handles, rigid probe with controls) and requires a patient contact return electrode to complete the circuit. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)654-2873custsvcnj@integralife.com

Regulatory Flags#

DUNS number
081277700
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10381780191070Integra® Jarit®400293400-2932018-04-02
10381780193180Integra® Jarit®P408P4082018-04-02
10381780197997Integra® Jarit®380232380-2322017-09-29
10381780198000Integra® Jarit®380233380-2332018-03-22
10381780198543Integra® Jarit®385295385-2952018-03-22
10381780220121Integra® Jarit®P666P6662018-01-31
10381780390381Integra® Jarit®380230380-2302018-02-16
10381780390398Integra® Jarit®380231380-2312018-02-16
10381780456469Integra® Jarit®405225405-2252018-01-31
10381780457190Integra® Jarit®P667P6672018-01-31
10381780458159Integra® Jarit®385315385-3152018-03-01
10381780458166Integra® Jarit®385316385-3162018-03-01
10381780487708Integra® Miltex®MH21-300MH21-3002018-08-22
10381780503910Integra® Miltex®PM-666PM-6662020-10-01
10381780520665CereLink™82684582-68452020-04-01
10381780087984Integra®375001237500122018-10-26
10381780081371Integra®372201137220112018-10-24
10381780081388Integra®372201237220122018-10-24
10381780081906Integra®372206937220692018-10-24
10381780081913Integra®372207037220702018-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00817401029178EndoplusEndoplusHET2026-07-08
00198506091452ELMED INCORPORATEDELMED INCORPORATEDHET2026-06-05
00198506091469ELMED INCORPORATEDELMED INCORPORATEDHET2026-06-05
00817401029161EndoplusEndoplusHET2026-06-05
10653405044703CORE DYNAMICSConmed CorporationHET2026-03-23
10887482155261Symmetry Secto®ASPEN SURGICAL PRODUCTS, INC.HET2024-09-09
10887482155285Symmetry Secto®ASPEN SURGICAL PRODUCTS, INC.HET2024-09-09
10887482155308Symmetry Secto®ASPEN SURGICAL PRODUCTS, INC.HET2024-09-09
10887482155322Symmetry Secto®ASPEN SURGICAL PRODUCTS, INC.HET2024-09-09
10381780538608Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538622Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538646Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538660Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538677Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538691Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538707Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538714Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538721Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538776MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538783MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538790Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538806Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538813Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538837MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538844MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538851Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538899Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538905Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538936Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538943Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29