Primary Device ID | D757X80498B1 |
NIH Device Record Key | d7053dd1-35ea-41d9-989a-d6fabfbebfca |
Commercial Distribution Discontinuation | 2020-02-04 |
Commercial Distribution Status | Not in Commercial Distribution |
Brand Name | ACE MIXING WELLS-WHITE-12 PKG |
Version Model Number | X-80498B |
Catalog Number | X-80498B |
Company DUNS | 053529939 |
Company Name | BISCO INC. |
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 | false |
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(847)534-6000 |
sales@bisco.com | |
Phone | +1(847)534-6000 |
sales@bisco.com | |
Phone | +1(847)534-6000 |
sales@bisco.com | |
Phone | +1(847)534-6000 |
sales@bisco.com | |
Phone | +1(847)534-6000 |
sales@bisco.com | |
Phone | +1(847)534-6000 |
sales@bisco.com | |
Phone | +1(847)534-6000 |
sales@bisco.com | |
Phone | +1(847)534-6000 |
sales@bisco.com | |
Phone | +1(847)534-6000 |
sales@bisco.com | |
Phone | +1(847)534-6000 |
sales@bisco.com | |
Phone | +1(847)534-6000 |
sales@bisco.com | |
Phone | +1(847)534-6000 |
sales@bisco.com | |
Phone | +1(847)534-6000 |
sales@bisco.com | |
Phone | +1(847)534-6000 |
sales@bisco.com | |
Phone | +1(847)534-6000 |
sales@bisco.com | |
Phone | +1(847)534-6000 |
sales@bisco.com |
Device Issuing Agency | Device ID |
---|---|
HIBCC | D757X80498B1 [Primary] |
KXR | Applicator, Resin |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2020-02-05 |
Device Publish Date | 2018-10-26 |
00810111542937 - TheraCal PT | 2024-04-11 TheraCal PT 2g Dual Syr |
00810111542944 - TheraCal PT | 2024-04-11 TheraCal PT 2g Syr Pkg |
D757B2501A1 - PRE-BOND Resin 3ml Btl | 2024-02-16 |
D757B36050 - Ace All-Bond TE Cartrdg(Pouch) | 2024-02-16 |
D757B36050P1 - Ace All-Bond TE 4 Cartrdg Pkg | 2024-02-16 |
D757B3605PS1 - ACE-All-Bond TE 1 CartridgePkg | 2024-02-16 |
D757B36100K1 - ACE All-Bond TE Starter Kit | 2024-02-16 |
D757B412010 - Ace Universal Primer A&B Cartridge-Pouch | 2024-02-16 |