Surgipoint
GUDID 10810020081999
Suture
RIVERPOINT MEDICAL, LLC
Polyester suture, bioabsorbable, monofilament| Primary Device ID | 10810020081999 |
| NIH Device Record Key | d1d997c6-1fb8-40a8-a2fc-3300e8bdc009 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Surgipoint |
| Version Model Number | Q395 |
| 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 | false |
| 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 | 00810020081992 [Primary] |
| GS1 | 10810020081999 [Package] Contains: 00810020081992 Package: [12 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K100461
FDA Product Code
| GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid |
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 | 2019-10-10 |
| Device Publish Date | 2019-10-02 |
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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