Primary Device ID | 04250381804032 |
NIH Device Record Key | 75c2f1ac-ab4d-4870-8624-6d2c237c10d3 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Total Middle Ear Implants |
Version Model Number | 11840 |
Catalog Number | 11840 |
Company DUNS | 332893028 |
Company Name | Spiggle & Theis Medizintechnik GmbH |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | MR Conditional |
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 | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | +492206908153 |
p.stockmann@spiggle-theis.com |
Length | 4 Millimeter |
Device Issuing Agency | Device ID |
---|---|
GS1 | 04250381804032 [Primary] |
ETA | Replacement, Ossicular Prosthesis, Total |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2019-06-17 |
Device Publish Date | 2019-06-07 |
04250381821503 - Gillies skin hook | 2025-10-07 fine 18.5 cm |
04250676710017 - Hook | 2025-10-07 curved, blunt 10.5 cm |
04250676711625 - Fork | 2025-10-07 curved 10.5 cm |
04250676716880 - ENT-single-use suction tubes, angled | 2025-10-07 transparent, Luer-Lock 130 x 2.0 mm, sterile, box of 50 |
04250676716897 - ENT-single-use suction tubes, angled | 2025-10-07 blue, Luer-Lock 130 x 3.0 mm, sterile, box of 50 |
04250676731982 - Salivary duct probe | 2025-10-07 straight, cylindrical 0.5 mm diameter |
04250676731999 - Salivary duct probe | 2025-10-07 straight, cylindrical 0.6 mm diameter |
04250676732002 - Salivary duct probe | 2025-10-07 straight, cylindrical 0.8 mm diameter |