UNIFY B-PD318R19
GUDID 10814639025764
Knotless Barbed PDO Sutures 3/0, 12" 19mm 3/8 Cir, Pc.
APPLIED DENTAL, INC.
Polyester suture, bioabsorbable, monofilament, non-antimicrobial| Primary Device ID | 10814639025764 |
| NIH Device Record Key | ae7429e7-3b74-4fba-b848-ef04a9d083b2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | UNIFY |
| Version Model Number | B-PD318R19 |
| Catalog Number | B-PD318R19 |
| Company DUNS | 017524666 |
| Company Name | APPLIED DENTAL, 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 | true |
| 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 |
Customer Support Contacts
| Phone | 1-888-841-8481 |
| info.usa@ad-surgical.com | |
| Phone | 1-888-841-8481 |
| info.usa@ad-surgical.com | |
| Phone | 1-888-841-8481 |
| info.usa@ad-surgical.com | |
| Phone | 1-888-841-8481 |
| info.usa@ad-surgical.com | |
| Phone | 1-888-841-8481 |
| info.usa@ad-surgical.com | |
| Phone | 1-888-841-8481 |
| info.usa@ad-surgical.com | |
| Phone | 1-888-841-8481 |
| info.usa@ad-surgical.com | |
| Phone | 1-888-841-8481 |
| info.usa@ad-surgical.com | |
| Phone | 1-888-841-8481 |
| info.usa@ad-surgical.com | |
| Phone | 1-888-841-8481 |
| info.usa@ad-surgical.com | |
| Phone | 1-888-841-8481 |
| info.usa@ad-surgical.com | |
| Phone | 1-888-841-8481 |
| info.usa@ad-surgical.com | |
| Phone | 1-888-841-8481 |
| info.usa@ad-surgical.com | |
| Phone | 1-888-841-8481 |
| info.usa@ad-surgical.com | |
| Phone | 1-888-841-8481 |
| info.usa@ad-surgical.com | |
| Phone | 1-888-841-8481 |
| info.usa@ad-surgical.com | |
| Phone | 1-888-841-8481 |
| info.usa@ad-surgical.com | |
| Phone | 1-888-841-8481 |
| info.usa@ad-surgical.com | |
| Phone | 1-888-841-8481 |
| info.usa@ad-surgical.com | |
| Phone | 1-888-841-8481 |
| info.usa@ad-surgical.com | |
| Phone | 1-888-841-8481 |
| info.usa@ad-surgical.com | |
| Phone | 1-888-841-8481 |
| info.usa@ad-surgical.com | |
| Phone | 1-888-841-8481 |
| info.usa@ad-surgical.com | |
| Phone | 1-888-841-8481 |
| info.usa@ad-surgical.com | |
| Phone | 1-888-841-8481 |
| info.usa@ad-surgical.com | |
| Phone | 1-888-841-8481 |
| info.usa@ad-surgical.com | |
| Phone | 1-888-841-8481 |
| info.usa@ad-surgical.com | |
| Phone | 1-888-841-8481 |
| info.usa@ad-surgical.com |
Operating and Storage Conditions
| Handling Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00814639025767 [Primary] |
| GS1 | 10814639025764 [Package] Contains: 00814639025767 Package: box [6 Units] In Commercial Distribution |
| GS1 | 20814639025761 [Package] Package: carton [50 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K193209
FDA Product Code
| NEW | Suture, Surgical, Absorbable, Polydioxanone |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-02-28 |
| Device Publish Date | 2022-02-18 |
On-Brand Devices [UNIFY ]
| 10814639025764 | Knotless Barbed PDO Sutures 3/0, 12" 19mm 3/8 Cir, Pc. |
| 10814639025757 | Knotless Barbed PDO Sutures with Stopper. 2/0, 18" 26mm Taper Pt 1/2 Cir, Pc. |
| 10814639025740 | Knotless Barbed PDO Sutures with Stopper. 2/0, 18" 36mm Taper Pt 1/2 Cir, Pc. |
Trademark Results [UNIFY]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 UNIFY 98527399 not registered Live/Pending |
UNIFY Financial Federal Credit Union 2024-04-30 |
 UNIFY 98210823 not registered Live/Pending |
Rutter Inc. 2023-10-05 |
 UNIFY 98210819 not registered Live/Pending |
Rutter Inc. 2023-10-05 |
 UNIFY 98126849 not registered Live/Pending |
Brahma Vella 2023-08-10 |
 UNIFY 98126842 not registered Live/Pending |
Brahma Vella 2023-08-10 |
 UNIFY 97936814 not registered Live/Pending |
FARO TECHNOLOGIES, INC. 2023-05-15 |
 UNIFY 97652483 not registered Live/Pending |
Red Nucleus Solutions Limited LiabilityCompany 2022-10-28 |
 UNIFY 97288491 not registered Live/Pending |
Nicolas Holdings LLC 2022-02-28 |
 UNIFY 97268714 not registered Live/Pending |
Acoustic, L.P. 2022-02-15 |
 UNIFY 90757623 not registered Live/Pending |
Junbo Huang 2021-06-07 |
 UNIFY 90591639 not registered Live/Pending |
Carlson, Ryan J. 2021-03-20 |
 UNIFY 90304979 not registered Live/Pending |
Unify Products LLC 2020-11-07 |
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