FDA.reportPublic FDA data

INTEGRA®

Primary DI
00650551003090
Brand
INTEGRA®
Company
PMT CORPORATION
Model
3611-674-3
Device description
TE TRAPEZOID, SMOOTH, 3-STAGE, MICRO REMOTE PORT, 3X5cm, 69cc FILL, PROJECTION 3cm
Published
2025-03-19
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
LCJTissue Expander And Accessories

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
00650551003090PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00650551003090006505510030906505510030900650551003090

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
039576871
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
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
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
00650551003410INTEGRA®PMT CORPORATIONLCJ2025-03-19