Primary Device ID | D0470136461 |
NIH Device Record Key | 4c046b64-a363-4a5c-91fc-90c9dbd6313a |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | G2-Bond Universal |
Version Model Number | 013646 |
Catalog Number | 013646 |
Company DUNS | 005473608 |
Company Name | Gc America Inc. |
Device Count | 1 |
DM Exempt | false |
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 | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 39.2 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *If not in use for a prolonged period of time, store in refrigerator. |
Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 39.2 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *If not in use for a prolonged period of time, store in refrigerator. |
Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 39.2 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *If not in use for a prolonged period of time, store in refrigerator. |
Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 39.2 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *If not in use for a prolonged period of time, store in refrigerator. |
Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 39.2 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *If not in use for a prolonged period of time, store in refrigerator. |
Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 39.2 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *If not in use for a prolonged period of time, store in refrigerator. |
Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 39.2 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *If not in use for a prolonged period of time, store in refrigerator. |
Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 39.2 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *If not in use for a prolonged period of time, store in refrigerator. |
Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 39.2 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *If not in use for a prolonged period of time, store in refrigerator. |
Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 39.2 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *If not in use for a prolonged period of time, store in refrigerator. |
Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 39.2 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *If not in use for a prolonged period of time, store in refrigerator. |
Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 39.2 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *If not in use for a prolonged period of time, store in refrigerator. |
Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 39.2 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *If not in use for a prolonged period of time, store in refrigerator. |
Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 39.2 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *If not in use for a prolonged period of time, store in refrigerator. |
Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 39.2 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *If not in use for a prolonged period of time, store in refrigerator. |
Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 39.2 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *If not in use for a prolonged period of time, store in refrigerator. |
Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 39.2 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *If not in use for a prolonged period of time, store in refrigerator. |
Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 39.2 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *If not in use for a prolonged period of time, store in refrigerator. |
Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 39.2 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *If not in use for a prolonged period of time, store in refrigerator. |
Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 39.2 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *If not in use for a prolonged period of time, store in refrigerator. |
Device Issuing Agency | Device ID |
---|---|
HIBCC | D0470136461 [Primary] |
KLE | AGENT, TOOTH BONDING, RESIN |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2021-07-29 |
Device Publish Date | 2021-07-21 |
D0470136521 | G2-Bond Universal 2-Bond Refill 5ml |
D0470136511 | G2-Bond Universal 1-Primer Refill 5ml |
D0470136461 | G2-Bond Universal Bottle Kit |
D0470136580 | G2-Bond Unvsl 2-Bond Btl Cover 50pk |
D0470136570 | G2-Bond Unvsl 1-Primer Btl Cover 50pk |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
G2-BOND UNIVERSAL 79306350 not registered Live/Pending |
GC Corporation 2020-12-25 |