FDA.reportPublic FDA data

Integra® Miltex®

Primary DI
10381780357971
Brand
Integra® Miltex®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
10308
Catalog number
10308
Device description
"Integra® Miltex® Varady Phlebectomy Extractor 6-3/4"", Micro Spatula, Double-Ended"
Published
2017-06-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GAISTRIPPER, VEIN, REUSABLE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAIStripper, Vein, ReusableGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780357971PrimaryGS10
H834103081SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178035797110381780357971

GMDN Terms#

Term, Definition table
TermDefinition
Vein stripper, reusableA hand-held surgical instrument designed to manually excise (strip by stab avulsion) a length or section of a vein from a patient, typically varicose veins [superficial dilated tortuous veins especially of the legs (greater saphenous veins)]. It is typically designed as: 1) a flexible stainless steel cable with a stripping cup or disk (commonly known as an olive) attached to one end, and a handle at the other (some types can employ a guide tip); or 2) a rigid or semi-rigid rod terminating in a closed ring or loop (also known as a ring stripper). This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

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
Premarket exempt
true
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

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Primary DI, Brand, Company table
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05055445928230SurtexSURTEX INSTRUMENTS LTD.GAI2026-05-12
05055445928247SurtexSURTEX INSTRUMENTS LTD.GAI2026-05-12
05055445928254SurtexSURTEX INSTRUMENTS LTD.GAI2026-05-12
05055445928261SurtexSURTEX INSTRUMENTS LTD.GAI2026-05-12
05055445928407SurtexSURTEX INSTRUMENTS LTD.GAI2026-05-12
05055445928414SurtexSURTEX INSTRUMENTS LTD.GAI2026-05-12
05055445928421SurtexSURTEX INSTRUMENTS LTD.GAI2026-05-12
05055445928438SurtexSURTEX INSTRUMENTS LTD.GAI2026-05-12
05055445928445SurtexSURTEX INSTRUMENTS LTD.GAI2026-05-12
05055445928452SurtexSURTEX INSTRUMENTS LTD.GAI2026-05-12
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08403207004444Anmuth Medical InternationalAnmuth Medical International, LLCGAI2024-07-01
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08403207004468Anmuth Medical InternationalAnmuth Medical International, LLCGAI2024-07-01
00840183505974BR Surgical, LLCBR Surgical, LLCGAI2024-06-03
00840183510206BR Surgical, LLCBR Surgical, LLCGAI2024-06-03
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