| Primary Device ID | 04250381808047 |
| NIH Device Record Key | 9837d6d4-3925-446f-90e5-ca7dc8e28b42 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Silicone Sheeting, non-sterile, blue |
| Version Model Number | 1760100-B |
| Catalog Number | 1760100-B |
| 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 | 04250381808047 [Primary] |
| LYA | SPLINT, INTRANASAL SEPTAL |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[04250381808047]
Moist Heat or Steam Sterilization
[04250381808047]
Moist Heat or Steam Sterilization
[04250381808047]
Moist Heat or Steam Sterilization
[04250381808047]
Moist Heat or Steam Sterilization
[04250381808047]
Moist Heat or Steam Sterilization
[04250381808047]
Moist Heat or Steam Sterilization
[04250381808047]
Moist Heat or Steam Sterilization
[04250381808047]
Moist Heat or Steam Sterilization
[04250381808047]
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 |
| 04250381808085 | 300 x 300 x 1.0 mm (900 cm²) 80 shore, 1 piece |
| 04250381808047 | 300x300x1.0 mm (900 cm²) 60 shore |