| Primary Device ID | 20841268108947 |
| NIH Device Record Key | 5f950feb-47e7-45f8-b83c-82f5def6c637 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Dilator |
| Version Model Number | DIL-113-02 |
| Catalog Number | DIL-113-02 |
| Company DUNS | 943156836 |
| Company Name | GALT MEDICAL CORP. |
| 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 | true |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Catheter Gauge | 4 French |
| Catheter Gauge | 4 French |
| Catheter Gauge | 4 French |
| Catheter Gauge | 4 French |
| Catheter Gauge | 4 French |
| Catheter Gauge | 4 French |
| Catheter Gauge | 4 French |
| Catheter Gauge | 4 French |
| Catheter Gauge | 4 French |
| Catheter Gauge | 4 French |
| Catheter Gauge | 4 French |
| Catheter Gauge | 4 French |
| Catheter Gauge | 4 French |
| Catheter Gauge | 4 French |
| Catheter Gauge | 4 French |
| Catheter Gauge | 4 French |
| Catheter Gauge | 4 French |
| Catheter Gauge | 4 French |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841268108943 [Primary] |
| GS1 | 10841268108940 [Package] Contains: 00841268108943 Package: Shelf Box [10 Units] In Commercial Distribution |
| GS1 | 20841268108947 [Package] Contains: 10841268108940 Package: Shipper Box [50 Units] In Commercial Distribution |
| DYB | Introducer, Catheter |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[20841268108947]
Ethylene Oxide
[20841268108947]
Ethylene Oxide
[20841268108947]
Ethylene Oxide
[20841268108947]
Ethylene Oxide
[20841268108947]
Ethylene Oxide
[20841268108947]
Ethylene Oxide
[20841268108947]
Ethylene Oxide
[20841268108947]
Ethylene Oxide
[20841268108947]
Ethylene Oxide
[20841268108947]
Ethylene Oxide
[20841268108947]
Ethylene Oxide
[20841268108947]
Ethylene Oxide
[20841268108947]
Ethylene Oxide
[20841268108947]
Ethylene Oxide
[20841268108947]
Ethylene Oxide
[20841268108947]
Ethylene Oxide
[20841268108947]
Ethylene Oxide
[20841268108947]
Ethylene Oxide
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-09-18 |
| Device Publish Date | 2019-09-10 |
| 20841268108343 | Dilator |
| 20841268107049 | Dilator |
| 20841268106912 | Dilator |
| 20841268100347 | Dilator |
| 20841268100330 | Dilator |
| 20841268100323 | Dilator |
| 20841268100316 | Dilator |
| 20841268100309 | Dilator |
| 20841268100293 | Dilator |
| 20841268100286 | Dilator |
| 20841268100279 | Dilator |
| 20841268100262 | Dilator |
| 20841268100255 | Dilator |
| 20841268100248 | Dilator |
| 20841268100231 | Dilator |
| 20841268100224 | Dilator |
| 20841268100217 | Dilator |
| 00841268100206 | Dilator |
| 00841268100190 | Dilator |
| 00841268100183 | Dilator |
| 00841268100176 | Dilator |
| 00841268100169 | Dilator |
| 00841268100152 | Dilator |
| 00841268100145 | Dilator |
| 00841268100138 | Dilator |
| 00841268100121 | Dilator |
| 00841268100114 | Dilator |
| 00841268100107 | Dilator |
| 20841268108947 | Dilator |
| 20841268108930 | Dilator |
| 10841268109466 | Dilator |
| 10841268109459 | Dilator |