| Primary Device ID | D023P006361 |
| NIH Device Record Key | de9de791-4bcf-46db-abf8-46d722a42f48 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Quala Suture Gut Chromic Suture |
| Version Model Number | P00636 |
| Catalog Number | P00636 |
| 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 | D023P006360 [Primary] |
| HIBCC | D023P006361 [Package] Contains: D023P006360 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 |
| M220720005 - Pro Advantage | 2025-09-19 PA DEPRESSOR TONGUE 6 NS 500/BX 10BX/CS - (CS) |
| M220761003 - Pro Advantage | 2025-09-19 PA APPLICATOR COTTON 3 NS WOOD 100/BG 10BG/BX 10BX/CS - (CS) |
| M220762003 - Pro Advantage | 2025-09-19 PA APPLICATOR COTTON 6 NS WOOD 100/BG 10BG/BX 10BX/CS - (CS) |
| M220767003 - Pro Advantage | 2025-09-19 PA APPLICATOR COTTON 6 NS WOOD 100/BG 10BG/BX 10BX/CS - (CS) |
| M220768003 - Pro Advantage | 2025-09-19 PA APPLICATOR COTTON 6 ST WOOD 2/PK 100PK/BX 10BX/CS - (CS) |
| M220768013 - Pro Advantage | 2025-09-19 PA APPLICATOR COTTON 6 ST PLAS 2/PK 100PK/BX 10BX/CS - (CS) |
| M220769003 - Pro Advantage | 2025-09-19 PA DEPRESSOR TONGUE 6 ST 1/PK 100PK/BX 10BX/CS - (CS) |
| M220770003 - Pro Advantage | 2025-09-19 PA DEPRESSOR TONGUE JR ST 1/PK 100PK/BX 10BX/CS - (CS) |