EdgeFind™
- Primary DI
- 10819514022425
- Brand
- EdgeFind™
- Company
- US ENDODONTICS, LLC
- Model
- EFNDP331
- Catalog number
- EFNDP331
- Device description
- EdgeFind™ P3 6 pack; 31
- Published
- 2023-06-25
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- true
Related Records
Contact Domains
us-endo.comProduct Codes
| Code | Name |
|---|---|
| EKS | FILE, PULP CANAL, ENDODONTIC |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| EKS | File, Pulp Canal, Endodontic | Dental | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00819514022428 | Primary | GS1 | 0 | |
| 10819514022425 | Unit of Use | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00819514022428 | 00819514022428 | 819514022428 | 0819514022428 |
| 10819514022425 | 10819514022425 |
GMDN Terms
| Term | Definition |
|---|---|
| Paediatric urine collection nappy | A non-sterile disposable undergarment (nappy or diaper) intended to be worn by an infant, at home or healthcare facility, to collect a paediatric urine specimen for subsequent laboratory analysis or home-testing. It resembles a conventional nappy and contains a urine accumulator which can be detached and used for the urine analysis. This is a single-use device. |
Sterilization Methods
| Method |
|---|
Contacts
| Phone | |
|---|---|
| +1(423)283-0047 | Bobby.bennett@us-endo.com |
Regulatory Flags
- DUNS number
- 061317427
- Device count
- 6
- DM exempt
- true
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- true
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 10810047645358 | EdgeSequel Utopia | ES150421SE | ES150421SE | 2023-07-28 |
| 10810047645365 | EdgeSequel Utopia | ES150425SE | ES150425SE | 2023-07-28 |
| 10810047645372 | EdgeSequel Utopia | ES150431SE | ES150431SE | 2023-07-28 |
| 10810047645389 | EdgeSequel Utopia | ES250421SE | ES250421SE | 2023-07-28 |
| 10810047645396 | EdgeSequel Utopia | ES250425SE | ES250425SE | 2023-07-28 |
| 10810047645402 | EdgeSequel Utopia | ES250431SE | ES250431SE | 2023-07-28 |
| 10810047645419 | EdgeSequel Utopia | ES300421SE | ES300421SE | 2023-07-28 |
| 10810047645426 | EdgeSequel Utopia | ES300425SE | ES300425SE | 2023-07-28 |
| 10810047645433 | EdgeSequel Utopia | ES300431SE | ES300431SE | 2023-07-28 |
| 10810047645440 | EdgeSequel Utopia | ES400421SE | ES400421SE | 2023-07-28 |
| 10810047645457 | EdgeSequel Utopia | ES400425SE | ES400425SE | 2023-07-28 |
| 10810047645464 | EdgeSequel Utopia | ES400431SE | ES400431SE | 2023-07-28 |
| 10810047645471 | EdgeSequel Utopia | ES500421SE | ES500421SE | 2023-07-28 |
| 10810047645488 | EdgeSequel Utopia | ES500425SE | ES500425SE | 2023-07-28 |
| 10810047645495 | EdgeSequel Utopia | ES500431SE | ES500431SE | 2023-07-28 |
| 10810047645501 | EdgeSequel Utopia | ES250621SE | ES250621SE | 2023-07-28 |
| 10810047645518 | EdgeSequel Utopia | ES250625SE | ES250625SE | 2023-07-28 |
| 10810047645525 | EdgeSequel Utopia | ES250631SE | ES250631SE | 2023-07-28 |
| 10810047645532 | EdgeSequel Utopia | ES300621SE | ES300621SE | 2023-07-28 |
| 10810047645549 | EdgeSequel Utopia | ES300625SE | ES300625SE | 2023-07-28 |
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 80810213810008 | EdgeEndo | HSG-S Corp. | EKS | 2026-03-23 |
| 80810213810015 | EdgeEndo | HSG-S Corp. | EKS | 2026-03-23 |
| 80810213810022 | EdgeEndo | HSG-S Corp. | EKS | 2026-03-23 |
| 80810213810039 | EdgeEndo | HSG-S Corp. | EKS | 2026-03-23 |
| 80810213810046 | EdgeEndo | HSG-S Corp. | EKS | 2026-03-23 |
| 80810213810053 | EdgeEndo | HSG-S Corp. | EKS | 2026-03-23 |
| 80810213810060 | EdgeEndo | HSG-S Corp. | EKS | 2026-03-23 |
| 80810213810077 | EdgeEndo | HSG-S Corp. | EKS | 2026-03-23 |
| 80810213810084 | EdgeEndo | HSG-S Corp. | EKS | 2026-03-23 |
| 80810213810091 | EdgeEndo | HSG-S Corp. | EKS | 2026-03-23 |
| 80810213810107 | EdgeEndo | HSG-S Corp. | EKS | 2026-03-23 |
| 80810213810114 | EdgeEndo | HSG-S Corp. | EKS | 2026-03-23 |
| 80810213810121 | EdgeEndo | HSG-S Corp. | EKS | 2026-03-23 |
| 80810213810138 | EdgeEndo | HSG-S Corp. | EKS | 2026-03-23 |
| 80810213810145 | EdgeEndo | HSG-S Corp. | EKS | 2026-03-23 |
| 80810213810152 | EdgeEndo | HSG-S Corp. | EKS | 2026-03-23 |
| 80810213810169 | EdgeEndo | HSG-S Corp. | EKS | 2026-03-23 |
| 80810213810176 | EdgeEndo | HSG-S Corp. | EKS | 2026-03-23 |
| 80810213810183 | EdgeEndo | HSG-S Corp. | EKS | 2026-03-23 |
| 80810213810190 | EdgeEndo | HSG-S Corp. | EKS | 2026-03-23 |
| 80810213810206 | EdgeEndo | HSG-S Corp. | EKS | 2026-03-23 |
| 80810213810213 | EdgeEndo | HSG-S Corp. | EKS | 2026-03-23 |
| 80810213810220 | EdgeEndo | HSG-S Corp. | EKS | 2026-03-23 |
| 80810213810237 | EdgeEndo | HSG-S Corp. | EKS | 2026-03-23 |
| 80810213810244 | EdgeEndo | HSG-S Corp. | EKS | 2026-03-23 |
| 80810213810251 | EdgeEndo | HSG-S Corp. | EKS | 2026-03-23 |
| 80810213810268 | EdgeEndo | HSG-S Corp. | EKS | 2026-03-23 |
| 80810213810275 | EdgeEndo | HSG-S Corp. | EKS | 2026-03-23 |
| 80810213810282 | EdgeEndo | HSG-S Corp. | EKS | 2026-03-23 |
| 80810213810299 | EdgeEndo | HSG-S Corp. | EKS | 2026-03-23 |