| Primary Device ID | D023P0007117 |
| NIH Device Record Key | f841bb5f-095c-4c5f-bb10-3d6043e38e5f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Quala Suture Silk |
| Version Model Number | P00071 |
| Catalog Number | P00071 |
| Company DUNS | 009831413 |
| Company Name | NATIONAL DISTRIBUTION & CONTRACTING, 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D023P0007106 [Primary] |
| HIBCC | D023P0007117 [Package] Contains: D023P0007106 Package: [12 Units] In Commercial Distribution |
| GAL | Suture, Absorbable, Natural |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2021-02-05 |
| Device Publish Date | 2017-02-13 |
| D023P0007218 | Quala suture silk black braided 3/0 18 C6 nonabsorable suture |
| D023P0007117 | Quala gut plain 4/0 18 C6 absorbable suture |
| D023P000661 | Quala silk black braided 4/0 18 C6 nonabsorable suture |
| D023P000651 | Sterile suture gut plain 3/0 18 C31 absorbable suture |
| D023P0006206 | Sterile silk black braided 3/0 18 C26 nonabsorbable suture |