INTEGRA® 3614ES-53

GUDID 00650551037125

TISSUE EXPANDER, CURVE, ENHANCED TEXTURED SURFACE

PMT CORPORATION

Skin-port tissue expander

• Primary Device ID: 00650551037125
• NIH Device Record Key: 906ff5eb-3362-4e1f-8963-44f956feba32
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INTEGRA®
• Version Model Number: 3614ES-53
• Catalog Number: 3614ES-53
• Company DUNS: 039576871
• Company Name: PMT CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-626-5463
• Email: info@pmtcorp.com
• Phone: 800-626-5463
• Email: info@pmtcorp.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between 58 Degrees Fahrenheit and 78 Degrees Fahrenheit
• Storage Environment Temperature: Between 58 Degrees Fahrenheit and 78 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00650551037125 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K845036

FDA Product Code

• LCJ: Expander, Skin, Inflatable

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-09-23
• Device Publish Date: 2016-08-11

On-Brand Devices [INTEGRA®]

• 00650551037569: BREAST EXPANDER, ANATOMICAL, ENHANCED TEXTURED SURFACE, INTERNAL RESEAL PORT, SUTURE TABS
• 00650551037552: BREAST EXPANDER, ANATOMICAL, ENHANCED TEXTURED SURFACE, INTERNAL RESEAL PORT
• 00650551037545: BREAST EXPANDER, ANATOMICAL, ENHANCED TEXTURED SURFACE
• 00650551037538: BREAST EXPANDER, ANATOMICAL, ENHANCED TEXTURED SURFACE, INTERNAL RESEAL PORT, SUTURE TABS
• 00650551037521: BREAST EXPANDER, ANATOMICAL, ENHANCED TEXTURED SURFACE, INTERNAL RESEAL PORT
• 00650551037514: BREAST EXPANDER, ANATOMICAL, ENHANCED TEXTURED SURFACE
• 00650551037507: BREAST EXPANDER, ANATOMICAL, ENHANCED TEXTURED SURFACE, INTERNAL RESEAL PORT, SUTURE TABS
• 00650551037491: BREAST EXPANDER, ANATOMICAL, ENHANCED TEXTURED SURFACE, INTERNAL RESEAL PORT
• 00650551037484: BREAST EXPANDER, ANATOMICAL, ENHANCED TEXTURED SURFACE
• 00650551037477: BREAST EXPANDER, ANATOMICAL, ENHANCED TEXTURED SURFACE, INTERNAL RESEAL PORT, SUTURE TABS
• 00650551037460: BREAST EXPANDER, ANATOMICAL, ENHANCED TEXTURED SURFACE, INTERNAL RESEAL PORT
• 00650551037453: BREAST EXPANDER, ANATOMICAL, ENHANCED TEXTURED SURFACE
• 00650551037446: BREAST EXPANDER, ANATOMICAL, SMOOTH, INTERNAL RESEAL PORT, SUTURE TABS
• 00650551037439: BREAST EXPANDER, ANATOMICAL, SMOOTH, INTERNAL RESEAL PORT
• 00650551037422: BREAST EXPANDER, ANATOMICAL, SMOOTH
• 00650551037415: BREAST EXPANDER, ANATOMICAL, SMOOTH, INTERNAL RESEAL PORT, SUTURE TABS
• 00650551037408: BREAST EXPANDER, ANATOMICAL, SMOOTH, INTERNAL RESEAL PORT
• 00650551037392: BREAST EXPANDER, ANATOMICAL, SMOOTH
• 00650551037385: BREAST EXPANDER, ANATOMICAL, SMOOTH, INTERNAL RESEAL PORT, SUTURE TABS
• 00650551037378: BREAST EXPANDER, ANATOMICAL, SMOOTH, INTERNAL RESEAL PORT
• 00650551037361: BREAST EXPANDER, ANATOMICAL, SMOOTH
• 00650551037354: BREAST EXPANDER, ANATOMICAL, SMOOTH, INTERNAL RESEAL PORT, SUTURE TABS
• 00650551037347: BREAST EXPANDER, ANATOMICAL, SMOOTH, INTERNAL RESEAL PORT
• 00650551037330: BREAST EXPANDER, ANATOMICAL, SMOOTH
• 00650551037323: TISSUE EXPANDER, CURVE, ENHANCED TEXTURED SURFACE, INTERNAL PORT
• 00650551037316: TISSUE EXPANDER, CURVE, ENHANCED TEXTURED SURFACE
• 00650551037309: TISSUE EXPANDER, CURVE, ENHANCED TEXTURED SURFACE, INTERNAL PORT
• 00650551037293: TISSUE EXPANDER, CURVE, ENHANCED TEXTURED SURFACE
• 00650551037286: TISSUE EXPANDER, CURVE, ENHANCED TEXTURED SURFACE, INTERNAL PORT
• 00650551037279: TISSUE EXPANDER, CURVE, ENHANCED TEXTURED SURFACE
• 00650551037262: TISSUE EXPANDER, CURVE, ENHANCED TEXTURED SURFACE, INTERNAL PORT
• 00650551037255: TISSUE EXPANDER, CURVE, ENHANCED TEXTURED SURFACE
• 00650551037248: TISSUE EXPANDER, CURVE, ENHANCED TEXTURED SURFACE, INTERNAL PORT
• 00650551037231: TISSUE EXPANDER, CURVE, ENHANCED TEXTURED SURFACE, 2-STAGE, INTERNAL PORT
• 00650551037224: TISSUE EXPANDER, CURVE, ENHANCED TEXTURED SURFACE, 2-STAGE
• 00650551037217: TISSUE EXPANDER, CURVE, ENHANCED TEXTURED SURFACE
• 00650551037200: TISSUE EXPANDER, CRESCENT, ENHANCED TEXTURED SURFACE, INTERNAL PORT
• 00650551037194: TISSUE EXPANDER, CRESCENT, ENHANCED TEXTURED SURFACE, EDGE PORT
• 00650551037187: TISSUE EXPANDER, CRESCENT, ENHANCED TEXTURED SURFACE, 2-STAGE, INTERNAL PORT
• 00650551037170: TISSUE EXPANDER, CRESCENT, ENHANCED TEXTURED SURFACE, 2-STAGE
• 00650551037163: TISSUE EXPANDER, CRESCENT, ENHANCED TEXTURED SURFACE
• 00650551037156: TISSUE EXPANDER, CURVE, ENHANCED TEXTURED SURFACE, INTERNAL PORT
• 00650551037149: TISSUE EXPANDER, CURVE, ENHANCED TEXTURED SURFACE, 2-STAGE, INTERNAL PORT
• 00650551037132: TISSUE EXPANDER, CURVE, ENHANCED TEXTURED SURFACE, 2-STAGE
• 00650551037125: TISSUE EXPANDER, CURVE, ENHANCED TEXTURED SURFACE
• 00650551037118: TISSUE EXPANDER, CURVE, ENHANCED TEXTURED SURFACE, INTERNAL PORT
• 00650551037101: TISSUE EXPANDER, CURVE, ENHANCED TEXTURED SURFACE
• 00650551037095: TISSUE EXPANDER, CURVE, ENHANCED TEXTURED SURFACE, INTERNAL PORT
• 00650551037088: TISSUE EXPANDER, CURVE, ENHANCED TEXTURED SURFACE, 2-STAGE, INTERNAL PORT
• 00650551037071: TISSUE EXPANDER, CURVE, ENHANCED TEXTURED SURFACE, 2-STAGE