DEVICE: INTEGRA® (00650551030027)
Device Identifier (DI) Information
INTEGRA®
3610ES-03
In Commercial Distribution
3610ES-03
PMT CORPORATION
3610ES-03
In Commercial Distribution
3610ES-03
PMT CORPORATION
TISSUE EXPANDER, RECTANGLE, ENHANCED TEXTURED SURFACE
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
Yes | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
45187 | Skin-port tissue expander |
An 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.
|
Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
LCJ | Expander, Skin, Inflatable |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K845036 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between 58 and 78 Degrees Fahrenheit |
Clinically Relevant Size
[?]Size Type Text |
---|
Device Size Text, specify: Projection 3 Centimeter |
Total Volume: 36 Centiliter |
Length: 5 Centimeter |
Width: 3 Centimeter |
Device Record Status
fda03a29-bfed-4c35-86df-208256384d34
September 23, 2019
4
August 10, 2016
September 23, 2019
4
August 10, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
800-626-5463
intl@pmtcorp.com 800-626-5463
info@pmtcorp.com
intl@pmtcorp.com 800-626-5463
info@pmtcorp.com