FDA.reportPublic FDA data

N/A

Primary DI
00650551045762
Brand
N/A
Company
PMT CORPORATION
Model
3608-21
Catalog number
3608-21
Device description
STANDARD REMOTE INJECTION PORT WITH SUTURE DISK
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MDMInstrument, Manual, Surgical, General Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MDMInstrument, Manual, Surgical, General UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00650551045762PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00650551045762006505510457626505510457620650551045762

GMDN Terms#

Term, Definition table
TermDefinition
Tissue expander injection portA device designed for subcutaneous implantation and intended to be used temporarily to expand an implanted tissue expander by percutaneous injection of air or fluids (e.g., saline) typically over multiple expansion sessions. It consists of an auto-sealing port for needle puncture and a tube connector for attachment to the tissue expander. It is available in a variety of designs. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-626-5463info@pmtcorp.com
800-626-5463intl@pmtcorp.com

Regulatory Flags#

DUNS number
039576871
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00650551006862ILSO™1515-08XM2026-07-17
00650551006879ITLSO™1535-08SF2026-07-17
00650551006886ITLSO™1535-08MF2026-07-17
00650551006893ITLSO™1535-08LF2026-07-17
00650551006909ITLSO™1535-08XF2026-07-17
00650551006916ITLSO™1535-08SM2026-07-17
00650551006923ITLSO™1535-08MM2026-07-17
00650551006930ITLSO™1535-08LM2026-07-17
00650551006947ITLSO™1535-08XM2026-07-17
00650551006954ILSO™1515-08CUSTOM2026-07-17
00650551006961ITLSO™1535-08CUSTOM2026-07-17

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506091988ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-22
00198506093470ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-22
00840456215753JMUJMU DENTAL, INCMDM2026-07-22
00840456218600JMUJMU DENTAL, INCMDM2026-07-22
00840456218617JMUJMU DENTAL, INCMDM2026-07-22
00190776403744MillenniumAvalign Technologies, Inc.MDM2026-07-21
00810005668125TrigonNVision Biomedical Technologies, Inc.MDM2026-04-24
00810005667227TrigonNVision Biomedical Technologies, Inc.MDM2025-12-19
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00810135963275ImpactNVision Biomedical Technologies, Inc.MDM2025-09-22
00810135962865TrigonNVision Biomedical Technologies, Inc.MDM2025-07-25
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00810135963107Caliber Intramedullary Fixation SystemNVision Biomedical Technologies, Inc.MDM2025-07-21
00810135962650TrigonNVision Biomedical Technologies, Inc.MDM2025-05-27
00810135962667TrigonNVision Biomedical Technologies, Inc.MDM2025-05-27