| Primary Device ID | E206B61661 |
| NIH Device Record Key | 32c12992-e7f3-48cd-943a-49496ac4852c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | E. Hahnenkratt GmbH |
| Version Model Number | B6166 |
| Company DUNS | 316001098 |
| Company Name | E. Hahnenkratt GmbH |
| Device Count | 3 |
| 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 | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | E206B61660 [Unit of Use] |
| HIBCC | E206B61661 [Primary] |
| EAX | Mirror, Mouth |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[E206B61661]
Moist Heat or Steam Sterilization
[E206B61661]
Moist Heat or Steam Sterilization
[E206B61661]
Moist Heat or Steam Sterilization
[E206B61661]
Moist Heat or Steam Sterilization
[E206B61661]
Moist Heat or Steam Sterilization
[E206B61661]
Moist Heat or Steam Sterilization
[E206B61661]
Moist Heat or Steam Sterilization
[E206B61661]
Moist Heat or Steam Sterilization
[E206B61661]
Moist Heat or Steam Sterilization
[E206B61661]
Moist Heat or Steam Sterilization
[E206B61661]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-09-12 |
| Device Publish Date | 2024-09-04 |
| E2066530X30 | Photo Mirror No. 3 single sided with handle |
| E206H950RX100 | with thread, Ø 10 mm |
| E206H757RX240 | with handle round, Ø 24 mm |
| E206H751RX180 | without thread, Ø 18 mm |
| E206B66961 | BLACK ULTRAretract, bifurcated stem, No. 5 plane |
| E206B66951 | BLACK ULTRAretract, bifurcated stem, No. 4 plane |
| E206B66911 | BLACK ULTRAretract, bifurcated stem, No. 5 plane |
| E206B66901 | BLACK ULTRAretract, bifurcated stem, No. 4 plane |
| E206B66861 | BLACK MEGAretract, bifurcated stem, No. 5 plane |
| E206B66851 | BLACK MEGAretract, bifurcated stem, No. 4 plane |
| E206B66811 | BLACK MEGAretract, bifurcated stem, No. 5 plane |
| E206B66801 | BLACK MEGAretract, bifurcated stem, No. 4 plane |
| E206B66451 | BLACK ULTRAduo, No. 4 plane |
| E206B66411 | BLACK ULTRAduo, No. 5 plane |
| E206B66401 | BLACK ULTRAduo, No. 4 plane |
| E206B62400 | 3x6 mm drop shaped |
| E206B62320 | oval 3x6 mm |
| E206B62200 | Ø 5 mm |
| E206B62000 | Ø 3 mm |
| E206B61840 | 3x6 mm drop shaped |
| E206B61830 | oval 3x6 mm |
| E206B61820 | Ø 5 mm |
| E206B61810 | Ø 3 mm |
| E206B61711 | BLACK MEGAduo, No. 5 plane |
| E206B61701 | BLACK MEGAduo, No. 4 plane |
| E206B61661 | BLACK ULTRA, No. 5 plane |
| E206B61651 | BLACK ULTRA, No. 4 plane |
| E206B61601 | BLACK ULTRA Mouth Mirror, No. 4 plane |
| E206B61011 | BLACK MEGAduo, No. 5 plane |
| E206B61001 | BLACK MEGAduo, No. 4 plane |
| E206B60711 | BLACK MEGA, No. 5 plane |
| E206B60701 | BLACK MEGA, No. 4 plane |
| E206B60611 | BLACK MEGA, No. 5 plane |
| E206B60601 | BLACK MEGA, No. 4 plane |
| E206B52400 | 3X6 mm drop shaped |
| E206B52320 | oval 3X6 mm |
| E206B52200 | Ø 5 mm |
| E206B52000 | Ø 3 mm |
| E206B51840 | 3X6 mm drop shaped |
| E206B51830 | oval 3X6 mm |
| E206B51820 | Ø 5 mm |
| E206B51810 | Ø 3 mm |
| E20673171 | No. 5 plane pink |
| E20673161 | No. 5 plane anthracite |
| E20673151 | No. 5 plane pastel lavender |
| E20673141 | No. 5 plane pastel mint |
| E20673131 | No. 5 plane pastel blue |
| E20673121 | No. 5 plane pastel yellow |
| E20673111 | No. 5 plane white |
| E20673101 | No. 5 plane, assortment |