Primary Device ID | J014660993180 |
NIH Device Record Key | ad9480bf-d1d6-4f42-8f47-993ea04c89cc |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Flexitime |
Version Model Number | 66099318 |
Catalog Number | 66099318 |
Company DUNS | 315666321 |
Company Name | Kulzer GmbH |
Device Count | 1 |
DM Exempt | true |
Pre-market Exempt | false |
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 | false |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | +1(574)291-0661 |
customerservice.na@kulzer-dental.com | |
Phone | +1(574)291-0661 |
customerservice.na@kulzer-dental.com | |
Phone | +1(574)291-0661 |
customerservice.na@kulzer-dental.com | |
Phone | +1(574)291-0661 |
customerservice.na@kulzer-dental.com | |
Phone | +1(574)291-0661 |
customerservice.na@kulzer-dental.com | |
Phone | +1(574)291-0661 |
customerservice.na@kulzer-dental.com | |
Phone | +1(574)291-0661 |
customerservice.na@kulzer-dental.com | |
Phone | +1(574)291-0661 |
customerservice.na@kulzer-dental.com | |
Phone | +1(574)291-0661 |
customerservice.na@kulzer-dental.com | |
Phone | +1(574)291-0661 |
customerservice.na@kulzer-dental.com | |
Phone | +1(574)291-0661 |
customerservice.na@kulzer-dental.com | |
Phone | +1(574)291-0661 |
customerservice.na@kulzer-dental.com | |
Phone | +1(574)291-0661 |
customerservice.na@kulzer-dental.com |
Device Issuing Agency | Device ID |
---|---|
HIBCC | J014660993180 [Primary] |
ELW | MATERIAL, IMPRESSION |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2025-06-18 |
Device Publish Date | 2025-06-10 |
J014661004810 | Flexitime unlimited Jumbo Pack 12x50ml |
J014660993210 | Flexitime unlimited Trial Kit |
J014660993200 | Flexitime unlimited 1x50ml |
J014660993190 | Flexitime unlimited Dynamix Trial Kit |
J014660993180 | Flexitime unlimited 1 x (2x50ml) |
J014660993170 | Flexitime unlimited Dynamix Refill (1x2x380ml) |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() FLEXITIME 76678414 3421146 Live/Registered |
KULZER GMBH 2007-06-19 |
![]() FLEXITIME 76093652 2569385 Live/Registered |
KULZER GMBH 2000-07-21 |