| Primary Device ID | D023P005581 |
| NIH Device Record Key | 9772c375-1252-48e3-b0a3-d3f84431cca5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Quala Chromic Gut Suture |
| Version Model Number | P00558 |
| Catalog Number | P00558 |
| 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 |
| Phone | 6153663225 |
| compliance@ndc-inc.com | |
| Phone | 6153663225 |
| compliance@ndc-inc.com | |
| Phone | 6153663225 |
| compliance@ndc-inc.com | |
| Phone | 6153663225 |
| compliance@ndc-inc.com | |
| Phone | 6153663225 |
| compliance@ndc-inc.com | |
| Phone | 6153663225 |
| compliance@ndc-inc.com | |
| Phone | 6153663225 |
| compliance@ndc-inc.com | |
| Phone | 6153663225 |
| compliance@ndc-inc.com | |
| Phone | 6153663225 |
| compliance@ndc-inc.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D023P005580 [Primary] |
| HIBCC | D023P005581 [Package] Contains: D023P005580 Package: [12 Units] |
| 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 |
| D023P006351 | Quala gut chromic 4/0 27 C-6 suture absorbable |
| D023P005581 | Quala chromic gut 4/0 18 C-6 absorbable suture |