| Primary Device ID | 04250381808054 |
| NIH Device Record Key | 4f9bf3f7-35aa-4cf6-8338-221daf097483 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Silicone sheeting |
| Version Model Number | 1762100-BSU |
| Catalog Number | 1762100-BSU |
| Company DUNS | 332893028 |
| Company Name | Spiggle & Theis Medizintechnik GmbH |
| 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 | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +492206908165 |
| c.winterschladen@spiggle-theis.com | |
| Phone | +492206908165 |
| c.winterschladen@spiggle-theis.com | |
| Phone | +492206908165 |
| c.winterschladen@spiggle-theis.com | |
| Phone | +492206908165 |
| c.winterschladen@spiggle-theis.com | |
| Phone | +492206908165 |
| c.winterschladen@spiggle-theis.com | |
| Phone | +492206908165 |
| c.winterschladen@spiggle-theis.com | |
| Phone | +492206908165 |
| c.winterschladen@spiggle-theis.com | |
| Phone | +492206908165 |
| c.winterschladen@spiggle-theis.com | |
| Phone | +492206908165 |
| c.winterschladen@spiggle-theis.com | |
| Phone | +492206908165 |
| c.winterschladen@spiggle-theis.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04250381808054 [Primary] |
| LYA | SPLINT, INTRANASAL SEPTAL |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[04250381808054]
Moist Heat or Steam Sterilization
[04250381808054]
Moist Heat or Steam Sterilization
[04250381808054]
Moist Heat or Steam Sterilization
[04250381808054]
Moist Heat or Steam Sterilization
[04250381808054]
Moist Heat or Steam Sterilization
[04250381808054]
Moist Heat or Steam Sterilization
[04250381808054]
Moist Heat or Steam Sterilization
[04250381808054]
Moist Heat or Steam Sterilization
[04250381808054]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-09-22 |
| Device Publish Date | 2025-09-12 |
| 04250381808054 | blue, 60 shore 70x55x1.0 mm, 25 pieces/box |
| 04250381808030 | transparent, 60 shore 300x300x1.0 mm |