CARDIONYL®
GUDID 13661522017385
PETERS SURGICAL
Nylon suture, non-bioabsorbable, monofilament| Primary Device ID | 13661522017385 |
| NIH Device Record Key | ebf90a32-d4e0-43ff-9818-5f88dc89aff0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CARDIONYL® |
| Version Model Number | 72106FH23 |
| Company DUNS | 265741780 |
| Company Name | PETERS SURGICAL |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Safe |
| 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 | 03661522017388 [Primary] |
| GS1 | 13661522017385 [Package] Contains: 03661522017388 Package: [36 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K913102
FDA Product Code
| GAR | Suture, nonabsorbable, synthetic, polyamide |
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 | 2020-01-17 |
| Device Publish Date | 2020-01-09 |
On-Brand Devices [CARDIONYL®]
Trademark Results [CARDIONYL]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CARDIONYL 76535974 2922132 Live/Registered |
PETERS SURGICAL 2003-07-25 |
 CARDIONYL 74357874 1967167 Dead/Cancelled |
PETERS LABORATORIES 1993-02-11 |
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