| Primary Device ID | 00667147001545 |
| NIH Device Record Key | 8d123377-d263-41f6-9bba-ed506d1ebae8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Polaroid DDS |
| Version Model Number | V8 |
| Catalog Number | PDDS |
| Company DUNS | 247111768 |
| Company Name | Synca Marketing Inc |
| 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 | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00667147001545 [Primary] |
| LLZ | System, Image Processing, Radiological |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-07-23 |
| Device Publish Date | 2021-07-15 |
| 00667147100088 - FIBER FORCE | 2021-08-03 PINK BRAIDED ROPE 1MM (2-150MM) |
| 00667147100095 - FIBER FORCE | 2021-08-03 PINK BRAIDED ROPE 2MM (2-150MM) |
| 00667147100101 - FIBER FORCE | 2021-08-03 PINK MESH (2-53MMx80MM) |
| 00667147100118 - FIBER FORCE | 2021-08-03 WHITE BRAIDED ROPE 2MM ( 2-150MM) |
| 00667147100125 - FIBER FORCE | 2021-08-03 PINK UD FIBERS (2-150MM) |
| 00667147100187 - FAST SPLINT MATRIX | 2021-08-03 COMPRESSIBLE HYBRID FIBERS 1:1 (5-55MM) |
| 00667147100194 - FAST SPLINT MATRIX | 2021-08-03 COMPRESSIBLE HYBRID FIBERS 1:4 (5-55MM) |
| 00667147100200 - FAST SPLINT MATRIX | 2021-08-03 ADHESIVE WAX STRIPS FOR 1:4 FIBERS (8-55MM) |