| Primary Device ID | B471102640600 |
| NIH Device Record Key | bb84a203-33bf-490c-b466-09f8655fa3fb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Jones/5th Metatarsal Bone Screw System |
| Version Model Number | 10264060 |
| Company DUNS | 080068420 |
| Company Name | GRAMERCY EXTREMITY ORTHOPEDICS 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 | false |
| Serial Number | true |
| Manufacturing Date | true |
| 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 |
| Phone | +1(855)436-2278 |
| GEOSupportCenter@gramercyortho.com | |
| Phone | +1(855)436-2278 |
| GEOSupportCenter@gramercyortho.com | |
| Phone | +1(855)436-2278 |
| GEOSupportCenter@gramercyortho.com | |
| Phone | +1(855)436-2278 |
| GEOSupportCenter@gramercyortho.com | |
| Phone | +1(855)436-2278 |
| GEOSupportCenter@gramercyortho.com | |
| Phone | +1(855)436-2278 |
| GEOSupportCenter@gramercyortho.com | |
| Phone | +1(855)436-2278 |
| GEOSupportCenter@gramercyortho.com | |
| Phone | +1(855)436-2278 |
| GEOSupportCenter@gramercyortho.com | |
| Phone | +1(855)436-2278 |
| GEOSupportCenter@gramercyortho.com | |
| Phone | +1(855)436-2278 |
| GEOSupportCenter@gramercyortho.com | |
| Phone | +1(855)436-2278 |
| GEOSupportCenter@gramercyortho.com | |
| Phone | +1(855)436-2278 |
| GEOSupportCenter@gramercyortho.com | |
| Phone | +1(855)436-2278 |
| GEOSupportCenter@gramercyortho.com | |
| Phone | +1(855)436-2278 |
| GEOSupportCenter@gramercyortho.com | |
| Phone | +1(855)436-2278 |
| GEOSupportCenter@gramercyortho.com |
| Length | 60 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 60 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 60 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 60 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 60 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 60 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 60 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 60 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 60 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 60 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 60 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 60 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 60 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 60 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 60 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B471102640600 [Primary] |
| HWC | Screw, fixation, bone |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-02-03 |
| Device Publish Date | 2021-01-26 |
| B471701000170 | 5th Metatarsal Common Kit |
| B471701000160 | 5th Metatarsal 6.5mm Kit |
| B471701000150 | 5th Metatarsal 5.5mm Kit |
| B471701000140 | 5th Metatarsal 4.5mm Kit |
| B471262000650 | Tapered Tap, 6.5mm, Cannulated AO |
| B471262000550 | Tapered Tap, 5.5mm, Cannulated AO |
| B471262000450 | Tapered Tap, 4.5mm, Cannulated AO |
| B471262000350 | Cannulated Tap, AO, 3.5mm |
| B471102661100 | Bone Screw 6.5x110 Headless Short Solid Ti |
| B471102661050 | Bone Screw 6.5x105 Headless Short Solid Ti |
| B471102661000 | Bone Screw 6.5x100 Headless Short Solid Ti |
| B471102660950 | Bone Screw 6.5x95 Headless Short Solid Ti |
| B471102660900 | Bone Screw 6.5x90 Headless Short Solid Ti |
| B471102660850 | Bone Screw 6.5x85 Headless Short Solid Ti |
| B471102660800 | Bone Screw 6.5x80 Headless Short Solid Ti |
| B471102660750 | Bone Screw 6.5x75 Headless Short Solid Ti |
| B471102660700 | Bone Screw 6.5x70 Headless Short Solid Ti |
| B471102660650 | Bone Screw 6.5x65 Headless Short Solid Ti |
| B471102660600 | Bone Screw 6.5x60 Headless Short Solid Ti |
| B471102660550 | Bone Screw 6.5x55 Headless Short Solid Ti |
| B471102660500 | Bone Screw 6.5x50 Headless Short Solid Ti |
| B471102660480 | Bone Screw 6.5x48 Headless Short Solid Ti |
| B471102660460 | Bone Screw 6.5x46 Headless Short Solid Ti |
| B471102660440 | Bone Screw 6.5x44 Headless Short Solid Ti |
| B471102660420 | Bone Screw 6.5x42 Headless Short Solid Ti |
| B471102660400 | Bone Screw 6.5x40 Headless Short Solid Ti |
| B471102660380 | Bone Screw 6.5x38 Headless Short Solid Ti |
| B471102660360 | Bone Screw 6.5x36 Headless Short Solid Ti |
| B471102660340 | Bone Screw 6.5x34 Headless Short Solid Ti |
| B471102660320 | Bone Screw 6.5x32 Headless Short Solid Ti |
| B471102660300 | Bone Screw 6.5x30 Headless Short Solid Ti |
| B471102650650 | Bone Screw 5.5x65 Headless Short Solid Ti |
| B471102650600 | Bone Screw 5.5x60 Headless Short Solid Ti |
| B471102650550 | Bone Screw 5.5x55 Headless Short Solid Ti |
| B471102650500 | Bone Screw 5.5x50 Headless Short Solid Ti |
| B471102650480 | Bone Screw 5.5x48 Headless Short Solid Ti |
| B471102650460 | Bone Screw 5.5x46 Headless Short Solid Ti |
| B471102650440 | Bone Screw 5.5x44 Headless Short Solid Ti |
| B471102650420 | Bone Screw 5.5x42 Headless Short Solid Ti |
| B471102650400 | Bone Screw 5.5x40 Headless Short Solid Ti |
| B471102650380 | Bone Screw 5.5x38 Headless Short Solid Ti |
| B471102650360 | Bone Screw 5.5x36 Headless Short Solid Ti |
| B471102650340 | Bone Screw 5.5x34 Headless Short Solid Ti |
| B471102650320 | Bone Screw 5.5x32 Headless Short Solid Ti |
| B471102650300 | Bone Screw 5.5x30 Headless Short Solid Ti |
| B471102640650 | Bone Screw 4.5x65 Headless Short Solid Ti |
| B471102640600 | Bone Screw 4.5x60 Headless Short Solid Ti |
| B471102640550 | Bone Screw 4.5x55 Headless Short Solid Ti |
| B471102640500 | Bone Screw 4.5x50 Headless Short Solid Ti |
| B471102640480 | Bone Screw 4.5x48 Headless Short Solid Ti |