| Primary Device ID | 00850001118071 |
| NIH Device Record Key | ffa662f9-1c22-431c-b0ec-7d7f5919e832 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GEM Cap™ |
| Version Model Number | LBCAP1216 |
| 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 | 12 Millimeter |
| Length | 12 Millimeter |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850001118071 [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 |
| 10850001118191 - GEM™ Wound Dressing Tape | 2020-07-07 Dental Wound Dressing Tape, 2.5cm x7.5cm x 1mm |
| 10850001118207 - GEM™ Wound Dressing Foam | 2020-07-07 Dental Wound Dressing Foam, 2cm x 4cm x 3mm |
| 10850001118214 - GEM™ Wound Dressing Plug | 2020-07-07 Dental Wound Dressing Plug, 10 x 20mm |
| 00850001118002 - GEM 21S® | 2018-11-19 Growth-Factor Enhanced Matrix for Periodontal Regeneration |
| 00850001118019 - GEM Adapt™ | 2018-11-19 Resorbable Collagen Membrane, 15mm x 20mm |
| 00850001118026 - GEM Adapt™ | 2018-11-19 Resorbable Collagen Membrane, 20mm x 30mm |
| 00850001118033 - GEM Adapt™ | 2018-11-19 Resorbable Collagen Membrane, 30mm x 40mm |
| 00850001118040 - GEM Extend™ | 2018-11-19 Resorbable Collagen Membrane, 15mm x 20mm |