| Primary Device ID | 00850001118064 |
| NIH Device Record Key | c36f6946-52bb-4285-afbf-e7ff5027e3de |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GEM Extend™ |
| Version Model Number | LBEXT3040 |
| Company DUNS | 079604282 |
| Company Name | LYNCH BIOLOGICS, LLC |
| 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 |
| Length | 30 Millimeter |
| Length | 30 Millimeter |
| Width | 40 Millimeter |
| Length | 30 Millimeter |
| Width | 40 Millimeter |
| Length | 30 Millimeter |
| Width | 40 Millimeter |
| Length | 30 Millimeter |
| Width | 40 Millimeter |
| Length | 30 Millimeter |
| Width | 40 Millimeter |
| Length | 30 Millimeter |
| Width | 40 Millimeter |
| Length | 30 Millimeter |
| Width | 40 Millimeter |
| Length | 30 Millimeter |
| Width | 40 Millimeter |
| Length | 30 Millimeter |
| Width | 40 Millimeter |
| Length | 30 Millimeter |
| Width | 40 Millimeter |
| Length | 30 Millimeter |
| Width | 40 Millimeter |
| Length | 30 Millimeter |
| Width | 40 Millimeter |
| Length | 30 Millimeter |
| Width | 40 Millimeter |
| Length | 30 Millimeter |
| Width | 40 Millimeter |
| Length | 30 Millimeter |
| Width | 40 Millimeter |
| Length | 30 Millimeter |
| Width | 40 Millimeter |
| Length | 30 Millimeter |
| Width | 40 Millimeter |
| Length | 30 Millimeter |
| Width | 40 Millimeter |
| Length | 30 Millimeter |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850001118064 [Primary] |
| NPL | Barrier, Animal Source, Intraoral |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-11-19 |
| Device Publish Date | 2018-10-18 |
| 00850001118064 | Resorbable Collagen Membrane, 30mm x 40mm |
| 00850001118057 | Resorbable Collagen Membrane, 20mm x 30mm |
| 00850001118040 | Resorbable Collagen Membrane, 15mm x 20mm |