FDA.reportPublic FDA data

INTEGRA

Primary DI
00650551006176
Brand
INTEGRA
Company
PMT CORPORATION
Model
3614-14-2-IR
Device description
INTEGRA TE, CRESCENT, STANDARD INTERNAL RESEAL PORT, 5X8CM, 200CC, 6CM PROJECTION, 2-STAGE, SMOOTH
Published
2026-05-18
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
00650551006176PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00650551006176006505510061766505510061760650551006176

GMDN Terms#

Term, Definition table
TermDefinition
Skin-port tissue expanderAn expandable device intended for implantation to temporarily enlarge tissue, typically the dimensions of a skin flap where there is insufficient tissue coverage to accommodate the volume of an implantable device (e.g., a breast implant), or for the revision of a scar or cutaneous defect. The device typically consists of an expansion envelope (e.g., silicone elastomer) with fill tube and an inflation valve, and is expanded percutaneously with air or fluid through a subcutaneous port accessed by a healthcare professional. This is a single-use device.

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00650551006572DEPTHALON®2102-06-005-NS2026-05-26
00650551006589DEPTHALON®2102-06-0052026-05-26
00650551005537DEPTHALON®2104-04-32-0012026-05-18
00650551005865MICROMAT®3105-M-B-122026-05-18
00650551005872MICROMAT®3105-M-Y-122026-05-18
00650551006022INTEGRA3610-76-ST2026-05-18
00650551006039INTEGRA3610-76-2-ST2026-05-18
00650551006046INTEGRA3611-690-2-ST2026-05-18
00650551006060INTEGRA3610-636-3-ST2026-05-18
00650551006077INTEGRA3611-230-2-ST2026-05-18
00650551006084INTEGRA3614-42-2-ST2026-05-18
00650551006091INTERCONNECTION CABLE2127-12-01-087-QDC2026-05-18
00650551006114CORTAC®2110-64-1692026-05-18
00650551006138DEPTHALON®2102-02-1912026-05-18
00650551006145INTERCONNECTION CABLE2127-16-04-Y92026-05-18
00650551006220INTERCONNECTION CABLE2120-10-0102026-05-18
00650551006237INTEGRA3611-691-IR-ST2026-05-18
00650551006459INTERCONNECTION CABLE2120-16-01-0112026-05-18
00650551006480INTERCONNECTION CABLE2127-16-04-Y10-NS2026-05-18
00650551006503INTEGRA3611-577-2-IR2026-05-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00650551006022INTEGRAPMT CORPORATIONLCJ2026-05-18
00650551006039INTEGRAPMT CORPORATIONLCJ2026-05-18
00650551006046INTEGRAPMT CORPORATIONLCJ2026-05-18
00650551006060INTEGRAPMT CORPORATIONLCJ2026-05-18
00650551006077INTEGRAPMT CORPORATIONLCJ2026-05-18
00650551006084INTEGRAPMT 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
00650551003410INTEGRA®PMT CORPORATIONLCJ2025-03-19
00650551003427INTEGRA®PMT CORPORATIONLCJ2025-03-19