Primary Device ID | 84548162300771 |
NIH Device Record Key | 38928108-684f-43d5-a4c2-a4deca9886bb |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | BeautiLink SA |
Version Model Number | C0209 |
Catalog Number | C0209 |
Company DUNS | 054618202 |
Company Name | SHOFU DENTAL CORPORATION |
Device Count | 2 |
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 | 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 | 760-736-3277 |
customer-service@shofu.com | |
Phone | 760-736-3277 |
customer-service@shofu.com | |
Phone | 760-736-3277 |
customer-service@shofu.com | |
Phone | 760-736-3277 |
customer-service@shofu.com | |
Phone | 760-736-3277 |
customer-service@shofu.com | |
Phone | 760-736-3277 |
customer-service@shofu.com | |
Phone | 760-736-3277 |
customer-service@shofu.com | |
Phone | 760-736-3277 |
customer-service@shofu.com | |
Phone | 760-736-3277 |
customer-service@shofu.com | |
Phone | 760-736-3277 |
customer-service@shofu.com | |
Phone | 760-736-3277 |
customer-service@shofu.com | |
Phone | 760-736-3277 |
customer-service@shofu.com | |
Phone | 760-736-3277 |
customer-service@shofu.com | |
Phone | 760-736-3277 |
customer-service@shofu.com |
Storage Environment Temperature | Between 1 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 1 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 1 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 1 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 1 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 1 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 1 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 1 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 1 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 1 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 1 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 1 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 1 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 1 Degrees Celsius and 25 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 04548162332592 [Primary] |
GS1 | 84548162300771 [Unit of Use] |
EMA | Cement, Dental |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-10-31 |
Device Publish Date | 2023-10-23 |
84548162300825 | BeautiLink SA Automix syringe 5mL (8.6g) Opaque 2pcs |
84548162300818 | BeautiLink SA Automix syringe 5mL (8.6g) Ivory 2pcs |
84548162300801 | BeautiLink SA Automix syringe 5mL (8.6g) Clear 2pcs |
84548162300795 | BeautiLink SA Handmix syringe 9mL (15.6g) Opaque 2pcs |
84548162300788 | BeautiLink SA Handmix syringe 9mL (15.6g) Ivory 2pcs |
84548162300771 | BeautiLink SA Handmix syringe 9mL (15.6g) Clear 2pcs |
04548162320513 | BeautiLink SA Automix syringe 2.5mL (4.4g) Opaque 1pc (SAMPLE) |
04548162320506 | BeautiLink SA Automix syringe 2.5mL (4.4g) Ivory 1pc (SAMPLE) |
04548162320490 | BeautiLink SA Automix syringe 2.5mL (4.4g) Clear 1pc (SAMPLE) |
04548162300829 | BeautiLink SA Automix syringe 5mL (8.6g) Opaque 1pc |
04548162300812 | BeautiLink SA Automix syringe 5mL (8.6g) Ivory 1pc |
04548162300805 | BeautiLink SA Automix syringe 5mL (8.6g) Clear 1pc |
04548162300799 | BeautiLink SA Handmix syringe 9mL (15.6g) Opaque 1pc |
04548162300782 | BeautiLink SA Handmix syringe 9mL (15.6g) Ivory 1pc |
04548162300775 | BeautiLink SA Handmix syringe 9mL (15.6g) Clear 1pc |