| Primary Device ID | 04250676731920 |
| NIH Device Record Key | bf9dafdb-1ee4-4586-a750-80783e6d0af2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Reference instrument |
| Version Model Number | 10-650-01 |
| Catalog Number | 10-650-01 |
| 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 | |
| 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 | 04250676731920 [Primary] |
| JZB | SCISSORS, EAR |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[04250676731920]
Moist Heat or Steam Sterilization
[04250676731920]
Moist Heat or Steam Sterilization
[04250676731920]
Moist Heat or Steam Sterilization
[04250676731920]
Moist Heat or Steam Sterilization
[04250676731920]
Moist Heat or Steam Sterilization
[04250676731920]
Moist Heat or Steam Sterilization
[04250676731920]
Moist Heat or Steam Sterilization
[04250676731920]
Moist Heat or Steam Sterilization
[04250676731920]
Moist Heat or Steam Sterilization
[04250676731920]
Moist Heat or Steam Sterilization
[04250676731920]
Moist Heat or Steam Sterilization
[04250676731920]
Moist Heat or Steam Sterilization
[04250676731920]
Moist Heat or Steam Sterilization
[04250676731920]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-10-03 |
| Device Publish Date | 2025-09-25 |
| 04250381857403 | for middle ear prostheses length 5.0 mm, 16 cm |
| 04250381857397 | for middle ear prostheses length 4.75 mm, 16 cm |
| 04250381857380 | for middle ear prostheses length 4.5 mm, 16 cm |
| 04250381857373 | for middle ear prostheses length 4.25 mm, 16 cm |
| 04250381857366 | for middle ear prostheses length 4.0 mm, 16 cm |
| 04250381857359 | for middle ear prostheses length 3.75 mm, 16 cm |
| 04250381857342 | for middle ear prostheses length 3.5 mm, 16 cm |
| 04250381857335 | for middle ear prostheses length 3.25 mm, 16 cm |
| 04250381857328 | for middle ear prostheses length 2.75 mm, 16 cm |
| 04250381857311 | for middle ear prostheses length 3.0 mm, 16 cm |
| 04250381857304 | for middle ear prostheses length 2.5 mm, 16 cm |
| 04250381849477 | for middle ear prostheses, slideable from 0-8 mm, 18.5 cm, dismountable |
| 04250381849460 | for middle ear prostheses, slidable 0-8 mm, 18.5 cm, non-dismountable |
| 04250381849453 | for stapes prostheses 3.5 / 4.0 / 4.5 mm, 16 cm |
| 04250676731920 | for stapes prostheses type Tübingen |