XSTAT FIN-0001-03
GUDID 10851587006056
A hemostatic device for severe bleeding. Each device comprises approximately 92 small hemostatic sponges individually marked with an X-shaped radiopaque marker.
REVMEDX, INC.
Radiopaque woven surgical sponge, sterile| Primary Device ID | 10851587006056 |
| NIH Device Record Key | b3ad1c65-4320-4ef6-9b09-bff965961e58 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | XSTAT |
| Version Model Number | XSTAT 30 |
| Catalog Number | FIN-0001-03 |
| Company DUNS | 961523441 |
| Company Name | REVMEDX, 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 | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 503-218-2172 |
| info@revmedx.com | |
| Phone | 503-218-2172 |
| info@revmedx.com | |
| Phone | 503-218-2172 |
| info@revmedx.com | |
| Phone | 503-218-2172 |
| info@revmedx.com | |
| Phone | 503-218-2172 |
| info@revmedx.com | |
| Phone | 503-218-2172 |
| info@revmedx.com | |
| Phone | 503-218-2172 |
| info@revmedx.com | |
| Phone | 503-218-2172 |
| info@revmedx.com | |
| Phone | 503-218-2172 |
| info@revmedx.com | |
| Phone | 503-218-2172 |
| info@revmedx.com | |
| Phone | 503-218-2172 |
| info@revmedx.com | |
| Phone | 503-218-2172 |
| info@revmedx.com | |
| Phone | 503-218-2172 |
| info@revmedx.com | |
| Phone | 503-218-2172 |
| info@revmedx.com | |
| Phone | 503-218-2172 |
| info@revmedx.com | |
| Phone | 503-218-2172 |
| info@revmedx.com | |
| Phone | 503-218-2172 |
| info@revmedx.com | |
| Phone | 503-218-2172 |
| info@revmedx.com | |
| Phone | 503-218-2172 |
| info@revmedx.com | |
| Phone | 503-218-2172 |
| info@revmedx.com | |
| Phone | 503-218-2172 |
| info@revmedx.com | |
| Phone | 503-218-2172 |
| info@revmedx.com | |
| Phone | 503-218-2172 |
| info@revmedx.com | |
| Phone | 503-218-2172 |
| info@revmedx.com | |
| Phone | 503-218-2172 |
| info@revmedx.com | |
| Phone | 503-218-2172 |
| info@revmedx.com | |
| Phone | 503-218-2172 |
| info@revmedx.com | |
| Phone | 503-218-2172 |
| info@revmedx.com | |
| Phone | 503-218-2172 |
| info@revmedx.com | |
| Phone | 503-218-2172 |
| info@revmedx.com | |
| Phone | 503-218-2172 |
| info@revmedx.com | |
| Phone | 503-218-2172 |
| info@revmedx.com | |
| Phone | 503-218-2172 |
| info@revmedx.com | |
| Phone | 503-218-2172 |
| info@revmedx.com | |
| Phone | 503-218-2172 |
| info@revmedx.com | |
| Phone | 503-218-2172 |
| info@revmedx.com | |
| Phone | 503-218-2172 |
| info@revmedx.com | |
| Phone | 503-218-2172 |
| info@revmedx.com | |
| Phone | 503-218-2172 |
| info@revmedx.com | |
| Phone | 503-218-2172 |
| info@revmedx.com | |
| Phone | 503-218-2172 |
| info@revmedx.com |
Device Dimensions
| Outer Diameter | 30 Millimeter |
| Outer Diameter | 30 Millimeter |
| Outer Diameter | 30 Millimeter |
| Outer Diameter | 30 Millimeter |
| Outer Diameter | 30 Millimeter |
| Outer Diameter | 30 Millimeter |
| Outer Diameter | 30 Millimeter |
| Outer Diameter | 30 Millimeter |
| Outer Diameter | 30 Millimeter |
| Outer Diameter | 30 Millimeter |
| Outer Diameter | 30 Millimeter |
| Outer Diameter | 30 Millimeter |
| Outer Diameter | 30 Millimeter |
| Outer Diameter | 30 Millimeter |
| Outer Diameter | 30 Millimeter |
| Outer Diameter | 30 Millimeter |
| Outer Diameter | 30 Millimeter |
| Outer Diameter | 30 Millimeter |
| Outer Diameter | 30 Millimeter |
| Outer Diameter | 30 Millimeter |
| Outer Diameter | 30 Millimeter |
| Outer Diameter | 30 Millimeter |
| Outer Diameter | 30 Millimeter |
| Outer Diameter | 30 Millimeter |
| Outer Diameter | 30 Millimeter |
| Outer Diameter | 30 Millimeter |
| Outer Diameter | 30 Millimeter |
| Outer Diameter | 30 Millimeter |
| Outer Diameter | 30 Millimeter |
| Outer Diameter | 30 Millimeter |
| Outer Diameter | 30 Millimeter |
| Outer Diameter | 30 Millimeter |
| Outer Diameter | 30 Millimeter |
| Outer Diameter | 30 Millimeter |
| Outer Diameter | 30 Millimeter |
| Outer Diameter | 30 Millimeter |
| Outer Diameter | 30 Millimeter |
| Outer Diameter | 30 Millimeter |
| Outer Diameter | 30 Millimeter |
| Outer Diameter | 30 Millimeter |
| Outer Diameter | 30 Millimeter |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Store device in room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store device in room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store device in room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store device in room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store device in room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store device in room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store device in room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store device in room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store device in room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store device in room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store device in room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store device in room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store device in room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store device in room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store device in room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store device in room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store device in room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store device in room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store device in room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store device in room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store device in room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store device in room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store device in room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store device in room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store device in room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store device in room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store device in room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store device in room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store device in room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store device in room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store device in room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store device in room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store device in room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store device in room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store device in room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store device in room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store device in room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store device in room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store device in room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store device in room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store device in room temperature |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00851587006059 [Primary] |
| GS1 | 10851587006056 [Package] Contains: 00851587006059 Package: Flexible Pouch [3 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K152624
FDA Product Code
| PGZ | Non-Absorbable, Expandable, Hemostatic Sponge For Temporary Internal Use |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-02 |
On-Brand Devices [XSTAT]
| 10851587006056 | A hemostatic device for severe bleeding. Each device comprises approximately 92 small hemostatic |
| 00851587006042 | A hemostatic device for severe bleeding. Each device comprises approximately 38 small hemostatic |
| 00851587006066 | A hemostatic device for severe bleeding. Each device comprises approximately 108 small hemostati |
Trademark Results [XSTAT]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 XSTAT 85475849 4584835 Live/Registered |
RevMedx, Inc. 2011-11-17 |
 XSTAT 73671262 1512407 Dead/Cancelled |
WINSTANDLEY & ASSOCIATES, INC. 1987-07-09 |
 XSTAT 73517804 not registered Dead/Abandoned |
MING TELECOMPUTING INC. 1985-01-16 |
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