ACCUSPAN® 3603-05
GUDID 00650551028437
TISSUE EXPANDER, MICRO, RECTANGLE
PMT CORPORATION
Skin-port tissue expander| Primary Device ID | 00650551028437 |
| NIH Device Record Key | 0999a45a-4e09-4776-a8fd-17d5f6423d7b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ACCUSPAN® |
| Version Model Number | 3603-05 |
| Catalog Number | 3603-05 |
| 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 |
| info@pmtcorp.com | |
| Phone | 800-626-5463 |
| info@pmtcorp.com |
Device Dimensions
| Width | 1 Centimeter |
| Width | 1 Centimeter |
| Width | 1 Centimeter |
| Width | 1 Centimeter |
| Width | 1 Centimeter |
| Width | 1 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 | 00650551028437 [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 | 2016-08-01 |
On-Brand Devices [ACCUSPAN®]
| 00650551028895 | TISSUE EXPANDER, CURVE |
| 00650551028888 | TISSUE EXPANDER, CURVE |
| 00650551028871 | TISSUE EXPANDER, CURVE |
| 00650551028864 | TISSUE EXPANDER, BREAST, TEARDROP |
| 00650551028857 | TISSUE EXPANDER, BREAST, TEARDROP |
| 00650551028840 | TISSUE EXPANDER, BREAST, TEARDROP |
| 00650551028833 | TISSUE EXPANDER, BREAST, ROUND |
| 00650551028826 | TISSUE EXPANDER, BREAST, STANDARD, ROUND |
| 00650551028819 | TISSUE EXPANDER, BREAST, ROUND |
| 00650551028802 | TISSUE EXPANDER, STANDARD, RECTANGLE |
| 00650551028796 | TISSUE EXPANDER, STANDARD, RECTANGLE |
| 00650551028789 | TISSUE EXPANDER, STANDARD, RECTANGLE |
| 00650551028772 | TISSUE EXPANDER, STANDARD, RECTANGLE |
| 00650551028765 | TISSUE EXPANDER, STANDARD, RECTANGLE |
| 00650551028758 | TISSUE EXPANDER, STANDARD, RECTANGLE |
| 00650551028741 | TISSUE EXPANDER, STANDARD, RECTANGLE |
| 00650551028734 | TISSUE EXPANDER, STANDARD, RECTANGLE |
| 00650551028727 | TISSUE EXPANDER, STANDARD, RECTANGLE |
| 00650551028710 | TISSUE EXPANDER, STANDARD, RECTANGLE |
| 00650551028703 | TISSUE EXPANDER, STANDARD, RECTANGLE |
| 00650551028697 | TISSUE EXPANDER, STANDARD, RECTANGLE |
| 00650551028680 | TISSUE EXPANDER, STANDARD, ROUND |
| 00650551028673 | TISSUE EXPANDER, STANDARD, RECTANGLE |
| 00650551028666 | TISSUE EXPANDER, STANDARD, RECTANGLE |
| 00650551028659 | TISSUE EXPANDER, STANDARD, RECTANGLE |
| 00650551028642 | TISSUE EXPANDER, STANDARD, RECTANGLE |
| 00650551028635 | TISSUE EXPANDER, STANDARD, RECTANGLE |
| 00650551028628 | TISSUE EXPANDER, STANDARD, ROUND |
| 00650551028611 | TISSUE EXPANDER, STANDARD, RECTANGLE |
| 00650551028604 | TISSUE EXPANDER, STANDARD, RECTANGLE |
| 00650551028598 | TISSUE EXPANDER, STANDARD, RECTANGLE |
| 00650551028581 | TISSUE EXPANDER, STANDARD, ROUND |
| 00650551028574 | TISSUE EXPANDER, MINI, RECTANGLE |
| 00650551028567 | TISSUE EXPANDER, MINI, RECTANGLE |
| 00650551028550 | TISSUE EXPANDER, MINI, RECTANGLE |
| 00650551028543 | TISSUE EXPANDER, MINI, RECTANGLE |
| 00650551028536 | TISSUE EXPANDER, MINI, RECTANGLE |
| 00650551028529 | TISSUE EXPANDER, MINI, RECTANGLE |
| 00650551028512 | TISSUE EXPANDER, MINI, RECTANGLE |
| 00650551028505 | TISSUE EXPANDER, MINI, RECTANGLE |
| 00650551028499 | TISSUE EXPANDER, MINI, RECTANGLE |
| 00650551028482 | TISSUE EXPANDER, MINI, RECTANGLE |
| 00650551028475 | TISSUE EXPANDER, MICRO, ROUND |
| 00650551028468 | TISSUE EXPANDER, MICRO, RECTANGLE |
| 00650551028451 | TISSUE EXPANDER, MICRO, RECTANGLE |
| 00650551028444 | TISSUE EXPANDER, MICRO, RECTANGLE |
| 00650551028437 | TISSUE EXPANDER, MICRO, RECTANGLE |
| 00650551028420 | TISSUE EXPANDER, MICRO, RECTANGLE |
| 00650551028413 | TISSUE EXPANDER, MICRO, RECTANGLE |
| 00650551028406 | TISSUE EXPANDER, MICRO, RECTANGLE |
Trademark Results [ACCUSPAN]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ACCUSPAN 98080103 not registered Live/Pending |
PMT Corporation 2023-07-11 |
 ACCUSPAN 74475959 not registered Dead/Abandoned |
AMERICAN TELEPHONE AND TELEGRAPH COMPANY 1994-01-03 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.