FDA.reportPublic FDA data

Integra

Primary DI
00650551001058
Brand
Integra
Company
PMT CORPORATION
Model
3610-625-2
Device description
TE, RECTANGLE SHAPE, 2-STAGE, SMOOTH SURFACE, MICRO REMOTE PORT TUBING, 3X7CM, 102CC FILL, 6CM PROJECTION
Published
2021-06-28
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

Product Codes#

Code, Name table
CodeName
LCJExpander, Skin, Inflatable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LCJTissue Expander And AccessoriesUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K845036000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K845036000TISSUE EXPANDERS FOR RECONSTRUC-SURGERY 3600Progress Mankind Technology1985-06-26LCJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00650551001058PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00650551001058006505510010586505510010580650551001058

GMDN Terms#

Term, Definition table
TermDefinition
Mechanical atherectomy system catheter, coronary/peripheralA sterile, flexible tube (catheter) intended to be percutaneously introduced for the intraluminal mechanical disruption of atheroma plaque from the walls of both coronary and peripheral arteries (or vein grafts). It has a power-driven cutting or abrasive head for slicing/grinding the atheroma into fragments small enough to be aspirated or absorbed. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
039576871
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10650551093616NEW BEGINNINGS® GEL SHEETING3505-12025-03-19
10650551093623NEW BEGINNINGS® GELSHAPES®3505-102025-03-19
10650551093630NEW BEGINNINGS® GELSHAPES®3505-112025-03-19
10650551093647NEW BEGINNINGS® GELSHAPES®3505-122025-03-19
10650551093654NEW BEGINNINGS® GELSHAPES®3505-22025-03-19
10650551093661NEW BEGINNINGS® GELSHAPES®3505-32025-03-19
10650551093678NEW BEGINNINGS® GELSHAPES®3505-42025-03-19
10650551093685NEW BEGINNINGS® GELSHAPES®3505-52025-03-19
10650551093692NEW BEGINNINGS® GELSHAPES®3505-82025-03-19
20650551093613NEW BEGINNINGS® GEL SHEETING3505-1-62025-03-19
20650551093620NEW BEGINNINGS® GELSHAPES®3505-10-62025-03-19
00650551006978PMT® SUCTION INSTRUMENTS9002-07-100-ST2026-07-20
00650551006992CORTAC®2110-08-1452026-07-20
00650551006794ILSO™1515-08SF2026-07-18
00650551006800ILSO™1515-08MF2026-07-17
00650551006817ILSO™1515-08LF2026-07-17
00650551006824ILSO™1515-08XF2026-07-17
00650551006831ILSO™1515-08SM2026-07-17
00650551006848ILSO™1515-08MM2026-07-17
00650551006855ILSO™1515-08LM2026-07-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00650551006596INTEGRAPMT CORPORATIONLCJ2026-05-27
00650551006022INTEGRAPMT CORPORATIONLCJ2026-05-18
00650551006039INTEGRAPMT CORPORATIONLCJ2026-05-18
00650551006046INTEGRAPMT CORPORATIONLCJ2026-05-18
00650551006060INTEGRAPMT CORPORATIONLCJ2026-05-18
00650551006077INTEGRAPMT CORPORATIONLCJ2026-05-18
00650551006084INTEGRAPMT CORPORATIONLCJ2026-05-18
00650551006176INTEGRAPMT CORPORATIONLCJ2026-05-18
00650551006237INTEGRAPMT CORPORATIONLCJ2026-05-18
00650551006503INTEGRAPMT CORPORATIONLCJ2026-05-18
00650551006510INTEGRAPMT CORPORATIONLCJ2026-05-18
00840124521889PolyLock MidfootFUSION ORTHOPEDICS, LLCLCJ2025-10-02
00650551005391INTEGRA®PMT CORPORATIONLCJ2025-03-26
10081317032332MENTOR CPX4 PLUS Enhance, Smooth, Tall HeightMENTOR TEXAS L.P.LCJ2025-03-26
00650551002154INTEGRA®PMT CORPORATIONLCJ2025-03-19
00650551002161INTEGRA®PMT CORPORATIONLCJ2025-03-19
00650551002772INTEGRA®PMT CORPORATIONLCJ2025-03-19
00650551002833INTEGRA®PMT CORPORATIONLCJ2025-03-19
00650551002963INTEGRA®PMT CORPORATIONLCJ2025-03-19
00650551003083INTEGRA®PMT CORPORATIONLCJ2025-03-19
00650551003090INTEGRA®PMT CORPORATIONLCJ2025-03-19
00650551003168INTEGRA®PMT CORPORATIONLCJ2025-03-19
00650551003175INTEGRA®PMT CORPORATIONLCJ2025-03-19
00650551003182INTEGRA®PMT CORPORATIONLCJ2025-03-19
00650551003205INTEGRA®PMT CORPORATIONLCJ2025-03-19
00650551003212INTEGRA®PMT CORPORATIONLCJ2025-03-19
00650551003243INTEGRA®PMT CORPORATIONLCJ2025-03-19
00650551003311INTEGRA®PMT CORPORATIONLCJ2025-03-19
00650551003328INTEGRA®PMT CORPORATIONLCJ2025-03-19
00650551003335INTEGRA®PMT CORPORATIONLCJ2025-03-19