SURGIPOINT
GUDID 10810020084075
Suture
RIVERPOINT MEDICAL, LLC
Polyester suture, bioabsorbable, monofilament, non-antimicrobial| Primary Device ID | 10810020084075 |
| NIH Device Record Key | 5948f608-72b7-4841-b2ee-15d6d907dd52 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SURGIPOINT |
| Version Model Number | D487 |
| Company DUNS | 964053560 |
| Company Name | RIVERPOINT MEDICAL, LLC |
| 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 | false |
| OTC Over-The-Counter | false |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810020084078 [Primary] |
| GS1 | 10810020084075 [Package] Contains: 00810020084078 Package: [12 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K100461
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 | 2020-10-19 |
| Device Publish Date | 2020-10-09 |
On-Brand Devices [SURGIPOINT]
Trademark Results [SURGIPOINT]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SURGIPOINT 85798651 4433870 Live/Registered |
Salvin Dental Specialties, Inc. 2012-12-10 |
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