| Primary Device ID | H3731PCM10137 |
| NIH Device Record Key | 4a89a63b-b291-4819-89bf-dc79b07ab400 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GORE PRECLUDE Pericardial Membrane |
| Version Model Number | 1PCM101 |
| Catalog Number | 1PCM101 |
| Company DUNS | 967358115 |
| Company Name | W. L. Gore & Associates, 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 | false |
| Serial Number | true |
| 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 |
| Length | 16 Centimeter |
| Length | 16 Centimeter |
| Length | 16 Centimeter |
| Length | 16 Centimeter |
| Length | 16 Centimeter |
| Length | 16 Centimeter |
| Width | 8 Centimeter |
| Height | 0 Millimeter |
| Length | 16 Centimeter |
| Width | 8 Centimeter |
| Height | 0 Millimeter |
| Length | 16 Centimeter |
| Width | 8 Centimeter |
| Height | 0 Millimeter |
| Length | 16 Centimeter |
| Width | 8 Centimeter |
| Height | 0 Millimeter |
| Length | 16 Centimeter |
| Width | 8 Centimeter |
| Height | 0 Millimeter |
| Length | 16 Centimeter |
| Width | 8 Centimeter |
| Height | 0 Millimeter |
| Length | 16 Centimeter |
| Width | 8 Centimeter |
| Height | 0 Millimeter |
| Length | 16 Centimeter |
| Width | 8 Centimeter |
| Height | 0 Millimeter |
| Length | 16 Centimeter |
| Width | 8 Centimeter |
| Height | 0 Millimeter |
| Length | 16 Centimeter |
| Width | 8 Centimeter |
| Height | 0 Millimeter |
| Length | 16 Centimeter |
| Width | 8 Centimeter |
| Height | 0 Millimeter |
| Length | 16 Centimeter |
| Width | 8 Centimeter |
| Height | 0 Millimeter |
| Length | 16 Centimeter |
| Width | 8 Centimeter |
| Height | 0 Millimeter |
| Length | 16 Centimeter |
| Width | 8 Centimeter |
| Height | 0 Millimeter |
| Length | 16 Centimeter |
| Width | 8 Centimeter |
| Height | 0 Millimeter |
| Length | 16 Centimeter |
| Width | 8 Centimeter |
| Height | 0 Millimeter |
| Length | 16 Centimeter |
| Width | 8 Centimeter |
| Height | 0 Millimeter |
| Length | 16 Centimeter |
| Width | 8 Centimeter |
| Height | 0 Millimeter |
| Length | 16 Centimeter |
| Width | 8 Centimeter |
| Height | 0 Millimeter |
| Length | 16 Centimeter |
| Width | 8 Centimeter |
| Height | 0 Millimeter |
| Length | 16 Centimeter |
| Width | 8 Centimeter |
| Height | 0 Millimeter |
| Length | 16 Centimeter |
| Width | 8 Centimeter |
| Height | 0 Millimeter |
| Length | 16 Centimeter |
| Width | 8 Centimeter |
| Height | 0 Millimeter |
| Length | 16 Centimeter |
| Width | 8 Centimeter |
| Height | 0 Millimeter |
| Length | 16 Centimeter |
| Width | 8 Centimeter |
| Height | 0 Millimeter |
| Length | 16 Centimeter |
| Width | 8 Centimeter |
| Height | 0 Millimeter |
| Length | 16 Centimeter |
| Width | 8 Centimeter |
| Height | 0 Millimeter |
| Length | 16 Centimeter |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00733132601820 [Primary] |
| HIBCC | H3731PCM10137 [Secondary] |
| DXZ | PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-02-13 |
| H3731PCM10339 | PCM 15.0 CM X 20.0 CM X 0.1 MM |
| H3731PCM10238 | PCM 12.0 CM X 12.0 CM X 0.1 MM |
| H3731PCM10137 | PCM 8.0 CM X 16.0 CM X 0.1 MM |
| H3731PCM10036 | PCM 6.0 CM X 12.0 CM X 0.1 MM |
| H3731PCM00136 | PCM 7.0CM X 10.0CM X 0.1MM |