| Primary Device ID | 00842102113147 |
| NIH Device Record Key | 4698c6e4-fd95-43e4-855d-d7b9a1d204ee |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DynaTrac Retractor Frame |
| Version Model Number | 78002-HP |
| Company DUNS | 047644935 |
| Company Name | FLEXBAR MACHINE CORPORATION |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| 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 | 00842102113147 [Primary] |
| GAD | Retractor |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00842102113147]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-04-15 |
| Device Publish Date | 2019-04-05 |
| 00842102113147 | DynaTrac Retractor Frame, Figure 8 with 2 Hex Posts, 15.3" (38.9cm) x 8.9" (22.6cm) |
| 00842102113130 | DynaTrac Retractor Frame, Square with Hex Post, 7.4" (18.8cm) x 7.4" (18.8cm) |
| 00842102113123 | DynaTrac Frame, Horesehoe with Hex Post 8.4" (21.3cm) x 7.8" (19.8cm) |
| 00842102115660 | DynaTrac Retractor Frame, Figure 8 with Dual Hex Posts, 15.3" x 8.9" |
| 00842102115837 | DynaTrac Retractor Frame, Square 7.4“ (18.8cm) x 7.4” (18.8cm) |
| 00842102115905 | DynaTrac Retractor Frame, Figure 8, 15.3" (38.9cm) x 8.9" (22.6cm) |
| 00842102115899 | DynaTrac Frame, Horesehoe, 8.4" (21.3cm) x 7.8" (19.8cm) |