Integra

GUDID 00650551002420

BE TEARDROP, SMOOTH, SINGLE STAGE, INTERNAL PORT, 10X13 CM SIZE, 450CC FILL, 7.5 PROJECTION

PMT CORPORATION

Skin-port tissue expander

• Primary Device ID: 00650551002420
• NIH Device Record Key: 0d9bcd3c-9533-4692-8b03-e1bde9b8ac9e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Integra
• Version Model Number: 3612-14I-ST
• 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: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00650551002420 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-10-29
• Device Publish Date: 2021-10-21

On-Brand Devices [Integra]

• 00650551149460: TE CRESCENT, SMOOTH SURFACE, TWO STAGE, REMOTE PORT, 4X6CM, 97CC FILL, 6CM PROJECTION
• 00650551148326: INTEGRA RECTANGLE, SMOOTH, 2-STAGE, REMOTE PORT TISSUE EXPANDER
• 00650551148319: INTEGRA, IRREGULAR CRESCENT SHAPE, SMOOTH SURFACE, 2-STAGE, REMOTE PORT TISSUE EXPANDER
• 00650551148302: INTEGRA, CRESCENT SHAPE, SMOOTH SURFACE, 2-STAGE, REMOTE PORT TISSUE EXPANDER
• 00650551148296: INTEGRA, IRREGULAR SHAPE, SMOOTH SURFACE, SINGLE STAGE, REMOTE PORT TISSUE EXPANDER
• 00650551147930: INTEGRA, ROUND BE SHAPE, SMOOTH SURFACE, SINGLE STAGE, REMOTE PORT TISSUE EXPANDER
• 00650551147923: INTEGRA, ROUND BE SHAPE, SMOOTH SURFACE, SINGLE STAGE, REMOTE PORT TISSUE EXPANDER
• 00650551147893: INTEGRA, ANATOMICAL TEARDROP SHAPE, SMOOTH SURFACE, SINGLE STAGE, INTERNAL PORT TISSUE EXPANDER
• 00650551147886: INTEGRA, LOW HEIGHT BE SHAPE, SMOOTH SURFACE, SINGLE STAGE, INTERNAL PORT TISSUE EXPANDER
• 00650551147824: INTEGRA, CURVE SHAPE, SMOOTH SURFACE, SINGLE STAGE, REMOTE PORT TISSUE EXPANDER WITH SUTURE TABS
• 00650551147169: INTEGRA, BE CRESCENT SHAPE, SMOOTH, SINGLE STAGE, INTERNAL PORT TISSUE EXPANDER WITH SUTURE TABS
• 00650551147152: INTEGRA, BE CRESCENT SHAPE, SMOOTH, SINGLE STAGE, INTERNAL PORT TISSUE EXPANDER WITH SUTURE TABS
• 00650551147145: INTEGRA, BE CRESCENT SHAPE, SMOOTH, SINGLE STAGE, INTERNAL PORT TISSUE EXPANDER WITH SUTURE TABS
• 00650551147053: INTEGRA, IRREGULAR SHAPE, SMOOTH, SINGLE STAGE, REMOTE PORT TISSUE EXPANDER WITH SUTURE TABS
• 00650551147046: INTEGRA, RECTANGLE SHAPE, SMOOTH, 2-STAGE, REMOTE PORT TISSUE EXPANDER WITH SUTURE TABS
• 00650551147039: INTEGRA, IRREGULAR SHAPE, SMOOTH, SINGLE STAGE, REMOTE PORT TISSUE EXPANDER
• 00650551146957: INTEGRA, ANATOMICAL SHAPE, SMOOTH, REMOTE PORT TISSUE EXPANDER
• 00650551146773: INTEGRA, LOW HEIGHT BE SHAPE, ENHANCED SURFACE, SINGLE STAGE, INTERNAL PORT TISSUE EXPANDER
• 00650551146766: INTEGRA, HOW HEIGHT BE SHAPE, ENHANCED SURFACE, SINGLE STAGE, INTERNAL PORT TISSUE EXPANDER
• 00650551146759: INTEGRA, ROUND SHAPE, SMOOTH, SINGLE STAGE, INTERNAL PORT TISSUE EXPANDER SUTURE TAB
• 00650551146612: INTEGRA, RECTANGE SHAPE, SMOOTH, 2-STAGE, REMOTE PORT TISSUE EXPANDER
• 00650551146605: INTEGRA, RECTANGE SHAPE, SMOOTH, SINGLE STAGE, REMOTE PORT TISSUE EXPANDER
• 00650551146599: INTEGRA, TEAR DROP SHAPE, SMOOTH, 2-STAGE, REMOTE PORT TISSUE EXPANDER
• 00650551146582: INTEGRA, TEAR DROP SHAPE, SMOOTH, 2-STAGE, REMOTE PORT TISSUE EXPANDER
• 00650551146575: INTEGRA, TEAR DROP SHAPE, SMOOTH, 2-STAGE, REMOTE PORT TISSUE EXPANDER
• 00650551146568: INTEGRA, TEAR DROP SHAPE, SMOOTH, 2-STAGE, REMOTE PORT TISSUE EXPANDER
• 00650551146551: INTEGRA, TEAR DROP SHAPE, SMOOTH, 2-STAGE, REMOTE PORT TISSUE EXPANDER
• 00650551146544: INTEGRA, TEAR DROP SHAPE, SMOOTH, 2-STAGE, REMOTE PORT TISSUE EXPANDER
• 00650551146537: INTEGRA, TEAR DROP SHAPE, SMOOTH, 2-STAGE, REMOTE PORT TISSUE EXPANDER
• 00650551146520: INTEGRA, TEAR DROP SHAPE, SMOOTH, 2-STAGE, REMOTE PORT TISSUE EXPANDER
• 00650551146476: INTEGRA, RECTANGLE SHAPE, SMOOTH, SINGLE STAGE, REMOTE PORT TISSUE EXPANDER
• 00650551144427: INTEGRA, RECTANGLE SHAPE, SMOOTH, 2-STAGE, MICRO REMOTE PORT TISSUE EXPANDER
• 00650551144410: INTEGRA ROUND SHAPE, SMOOTH, SINGLE STAGE, INTERNAL PORT TISSUE EXPANDER
• 00650551144366: INTEGRA ROUND SHAPE, SMOOTH, SINGLE STAGE, REMOTE PORT TISSUE EXPANDER
• 00650551144267: INTEGRA RECTANGE SHAPE, SMOOTH, 2-STAGE, REMOTE PORT, SUTURE TAB TISSUE EXPANDER
• 00650551144236: INTEGRA IRREGULAR SHAPE, SMOOTH, 2-STAGE, REMOTE PORT TISSUE EXPANDER
• 00650551144229: INTEGRA IRREGULAR SHAPE, SMOOTH, 2-STAGE, REMOTE PORT TISSUE EXPANDER
• 00650551144199: INTEGRA CYLINDER SHAPE, SMOOTH, SINGLE STAGE, REMOTE PORT, SUTURE TABS, TISSUE EXPANDER
• 00650551144113: INTEGRA CURVE SHAPE, SMOOTH, SINGLE STAGE, REMOTE PORT TISSUE EXPANDER
• 00650551144106: INTEGRA IRREGULAR SHAPE, SMOOTH, SINGLE STAGE, REMOTE PORT TISSUE EXPANDER
• 00650551144090: INTEGRA IRREGULAR SHAPE, SMOOTH, SINGLE STAGE, REMOTE PORT TISSUE EXPANDER
• 00650551144083: INTEGRA IRREGULAR SHAPE, SMOOTH, SINGLE STAGE, REMOTE PORT TISSUE EXPANDER
• 00650551144076: INTEGRA IRREGULAR SHAPE, SMOOTH, SINGLE STAGE, REMOTE PORT TISSUE EXPANDER
• 00650551144069: INTEGRA, IRREGULAR SHAPE, SMOOTH, SINGLE STAGE, REMOTE PORT TISSUE EXPANDER
• 00650551023302: INTEGRA, WB OVAL SHAPE, ENHANCED SURFACE, 2-STAGE, INTERNAL PORT TISSUE EXPANDER
• 00650551149934: INTEGRA, TEARDROP SHAPE, SMOOTH SURFACE, 2-STAGE, INTERNAL PORT WITH SUTURE TABS
• 00650551149927: INTEGRA, ROUND SHAPE, SMOOTH SURFACE, SINGLE STAGE, REMOTE PORT WITH SUTURE TABS
• 00650551149910: INTEGRA, ROUND SHAPE, SMOOTH SURFACE, SINGLE STAGE, INTERNAL PORT
• 00650551149859: INTEGRA, ROUND SHAPE, SMOOTH SURFACE, SINGLE STAGE, INTERNAL PORT
• 00650551149828: INTEGRA, ROUND SHAPE, SMOOTH SURFACE, SINGLE STAGE, REMOTE PORT WITH SUTURE TABS