| Primary Device ID | 00696588005331 |
| NIH Device Record Key | c89fef90-97bf-4455-87ae-86519ff4bfb8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | De Mayo Ankle Distractor™ |
| Version Model Number | 1109-SYS KIT LOANER |
| Catalog Number | 1109-SYS KIT LOANER |
| Company DUNS | 147363154 |
| Company Name | Innovative Medical Products, Inc |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00696588005331 [Primary] |
| FWZ | Operating Room Accessories Table Tray |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00696588005331]
Moist Heat or Steam Sterilization
[00696588005331]
Moist Heat or Steam Sterilization
[00696588005331]
Moist Heat or Steam Sterilization
[00696588005331]
Moist Heat or Steam Sterilization
[00696588005331]
Moist Heat or Steam Sterilization
[00696588005331]
Moist Heat or Steam Sterilization
[00696588005331]
Moist Heat or Steam Sterilization
[00696588005331]
Moist Heat or Steam Sterilization
[00696588005331]
Moist Heat or Steam Sterilization
[00696588005331]
Moist Heat or Steam Sterilization
[00696588005331]
Moist Heat or Steam Sterilization
[00696588005331]
Moist Heat or Steam Sterilization
[00696588005331]
Moist Heat or Steam Sterilization
[00696588005331]
Moist Heat or Steam Sterilization
[00696588005331]
Moist Heat or Steam Sterilization
[00696588005331]
Moist Heat or Steam Sterilization
[00696588005331]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-11-18 |
| Device Publish Date | 2019-11-08 |
| 00696588002439 | De Mayo Ankle Distractor™ System (1 ea - 1109, 907 and 713-302) |
| 00696588002422 | De Mayo Ankle Distractor™ System (1 ea - 1109, 907 and 903) |
| 00696588001531 | De Mayo Ankle Distractor Accessory (For Posterior Approach) |
| 00696588001524 | De Mayo Ankle Distractor™ Base & Bridge |
| 00696588004099 | De Mayo Ankle Distractor™ Sterilization Cases (1 each of 1109-XS and 1109-S) |
| 00696588004044 | De Mayo Ankle Distractor™ Sterilization Case (907 & Clamp) 14.5" x 10.5" x 6.5" |
| 00696588003931 | Aluminum Boot Attachment with Pin-Horseshoe Attachment & Pin Holder for De Mayo Ankle Distractor |
| 00696588003900 | 1109 Sawbones base & bridge |
| 00696588001548 | De Mayo Ankle Distractor™ Sterilization Case (Base & Bridge) 32" x 12" x 2.5" |
| 00696588004730 | Loaner De Mayo Ankle Distractor™ Base & Bridge |
| 00696588004723 | Demo De Mayo Ankle Distractor™ Base & Bridge |
| 00696588005348 | Demo De Mayo Ankle Distractor™ Sterilization Cases (1 each of 1109-XS and 1109-S) |
| 00696588005331 | Loaner De Mayo Ankle Distractor™ System (1ea-1109, 907, and 903) |
| 00696588006956 | De Mayo Ankle Distractor™ System (1 ea - 1109, 907 and 713-717) |