REALM® 3614ES-50-RB

GUDID 00650551143611

TISSUE EXPANDER, CURVE, ENHANCED TEXTURED SURFACE

PMT CORPORATION

Skin-port tissue expander Skin-port tissue expander

• Primary Device ID: 00650551143611
• NIH Device Record Key: 2b973c03-efee-40ed-be50-0dc5413dabb7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: REALM®
• Version Model Number: 3614ES-50-RB
• Catalog Number: 3614ES-50-RB
• 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

• Width: 5.7 Centimeter
• Width: 5.7 Centimeter
• Width: 5.7 Centimeter
• Width: 5.7 Centimeter
• Width: 5.7 Centimeter
• Width: 5.7 Centimeter
• Width: 5.7 Centimeter
• Width: 5.7 Centimeter

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	00650551143611 [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: 2
• Public Version Date: 2019-09-23
• Device Publish Date: 2018-11-06

On-Brand Devices [REALM®]

• 00650551143673: TISSUE EXPANDER, RECTANGLE, SMOOTH, INTERNAL PORT
• 00650551143666: TISSUE EXPANDER, ROUND, SMOOTH, SUTURE TABS
• 00650551143659: TISSUE EXPANDER, ROUND, SMOOTH, SUTURE TABS
• 00650551143642: TISSUE EXPANDER, RECTANGLE, SMOOTH, SUTURE TABS
• 00650551143635: TISSUE EXPANDER, RECTANGLE, SMOOTH, SUTURE TABS
• 00650551143628: TISSUE EXPANDER, ROUND, SMOOTH, SUTURE TABS
• 00650551143611: TISSUE EXPANDER, CURVE, ENHANCED TEXTURED SURFACE
• 00650551143604: TISSUE EXPANDER, SQUARE, SMOOTH, INTERNAL PORT
• 00650551143598: TISSUE EXPANDER, RECTANGLE, SMOOTH, INTERNAL PORT
• 00650551143581: TISSUE EXPANDER, RECTANGLE, SMOOTH, 2-STAGE, INTERNAL PORT
• 00650551143574: TISSUE EXPANDER, RECTANGLE, SMOOTH
• 00650551143567: TISSUE EXPANDER, SQUARE, SMOOTH
• 00650551143550: TISSUE EXPANDER, RECTANGLE, SMOOTH, 2-STAGE, INTERNAL PORT
• 00650551143543: TISSUE EXPANDER, RECTANGLE, SMOOTH, 2-STAGE, INTERNAL PORT
• 00650551143536: TISSUE EXPANDER, ROUNDED, SMOOTH
• 00650551143529: TISSUE EXPANDER, RECTANGLE, SMOOTH, 2-STAGE
• 00650551143512: TISSUE EXPANDER, RECTANGLE, SMOOTH, 2-STAGE
• 00650551143505: TISSUE EXPANDER, RECTANGLE, SMOOTH, 2-STAGE
• 00650551143499: TISSUE EXPANDER, RECTANGLE, SMOOTH, 2-STAGE
• 00650551143482: TISSUE EXPANDER, RECTANGLE, SMOOTH, 2-STAGE