Primary Device ID | E29959700 |
NIH Device Record Key | 82107f8f-e3f4-4746-bc58-196fdd6922a9 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Fiber-Splint |
Version Model Number | 5970 |
Company DUNS | 481461598 |
Company Name | Polydentia SA |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | MR Safe |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
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 |
---|---|
HIBCC | E29959700 [Primary] |
EBI | Resin, Denture, Relining, Repairing, Rebasing |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2016-09-28 |
E29950029 - wood wedges | 2025-06-24 |
E2995018MN9 - Orange wood wedges | 2025-06-24 |
E2995018PLUS9 - Orange wood wedges | 2025-06-24 |
E2995018S9 - Orange wood wedges | 2025-06-24 |
E29968900 - myQuickmat Prime Kit | 2025-06-24 |
E29968919 - myRing Prime | 2025-06-24 |
E29968929 - myTines Prime | 2025-06-24 |
E29968939 - Quickmat Prime | 2025-06-24 |