Primary Device ID | D824PS2NC32162 |
NIH Device Record Key | 4bc55101-5c41-464e-8cf5-df274ef869d3 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Solution5 Implant Pack |
Version Model Number | PS2NC3216 |
Company DUNS | 080321629 |
Company Name | SURGIKOR, 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 | true |
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 | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
HIBCC | D824PS2NC32160 [Primary] |
HIBCC | D824PS2NC32161 [Package] Contains: D824PS2NC32160 Package: [10 Units] In Commercial Distribution |
HIBCC | D824PS2NC32162 [Package] Contains: D824PS2NC32160 Package: [4 Units] In Commercial Distribution |
DZE | Implant, Endosseous, Root-Form |
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 | 2017-02-06 |
D824PS5WC50152 | Ø5.0mm x L15.0 mm, Conical Connection, Wide Platform with Cover Screw & Mount |
D824PS5WC50132 | Ø5.0mm x L13.0 mm, Conical Connection, Wide Platform with Cover Screw & Mount |
D824PS5WC50112 | Ø5.0mm x L11.0 mm, Conical Connection, Wide Platform with Cover Screw & Mount |
D824PS5WC50102 | Ø5.0mm x L10.0 mm, Conical Connection, Wide Platform with Cover Screw & Mount |
D824PS5WC50082 | Ø5.0mm x L8.0 mm, Conical Connection, Wide Platform with Cover Screw & Mount |
D824PS5WC50072 | Ø5.0mm x L7.0 mm, Conical Connection, Wide Platform with Cover Screw & Mount |
D824PS5WC45152 | Ø4.5mm x L15.0 mm, Conical Connection, Wide Platform with Cover Screw & Mount |
D824PS5WC45132 | Ø4.5mm x L13.0 mm, Conical Connection, Wide Platform with Cover Screw & Mount |
D824PS5WC45112 | Ø4.5mm x L11.0 mm, Conical Connection, Wide Platform with Cover Screw & Mount |
D824PS5WC45102 | Ø4.5mm x L10.0 mm, Conical Connection, Wide Platform with Cover Screw & Mount |
D824PS5WC45082 | Ø4.5mm x L8.0 mm, Conical Connection, Wide Platform with Cover Screw & Mount |
D824PS5WC45072 | Ø4.5mm x L7.0 mm, Conical Connection, Wide Platform with Cover Screw & Mount |
D824PS5WC40152 | Ø4.0mm x L15.0 mm, Conical Connection, Wide Platform with Cover Screw & Mount |
D824PS5WC40132 | Ø4.0mm x L13.0 mm, Conical Connection, Wide Platform with Cover Screw & Mount |
D824PS5WC40112 | Ø4.0mm x L11.5 mm, Conical Connection, Wide Platform with Cover Screw & Mount |
D824PS5WC40102 | Ø4.0mm x L10.0 mm, Conical Connection, Wide Platform with Cover Screw & Mount |
D824PS5WC40082 | Ø4.0mm x L8.5 mm, Conical Connection, Wide Platform with Cover Screw & Mount |
D824PS5WC40072 | Ø4.0mm x L7.0 mm, Conical Connection, Wide Platform with Cover Screw & Mount |
D824PS5RC35152 | Ø3.5mm x L15.0mm, Conical Connection, Regular Platform with Cover Screw & Mount |
D824PS5RC35132 | Ø3.5mm x L13.0mm, Conical Connection, Regular Platform with Cover Screw & Mount |
D824PS5RC35112 | Ø3.5mm x L11.5.0mm, Conical Connection, Regular Platform with Cover Screw & Mount |
D824PS5RC35102 | Ø3.5mm x L10.0mm, Conical Connection, Regular Platform with Cover Screw & Mount |
D824PS5RC35082 | Ø3.5mm x L8.5 mm, Conical Connection, Regular Platform with Cover Screw & Mount |
D824PS5NC32162 | Ø3.25mm x L16.0mm, Conical Connection, Narrow Platform with Cover Screw & Mount |
D824PS5NC32132 | Ø3.25mm x L13.0mm, Conical Connection, Narrow Platform with Cover Screw & Mount |
D824PS5NC32112 | Ø3.25mm x L11.5mm, Conical Connection, Narrow Platform with Cover Screw & Mount |
D824PS5NC32102 | Ø3.25mm x L10.0mm, Conical Connection, Narrow Platform with Cover Screw & Mount |
D824PS5NC30162 | Ø3.0mm x L16.0mm, Conical Connection, Narrow Platform with Cover Screw & Mount |
D824PS5NC30132 | Ø3.0mm x L13.0mm, Conical Connection, Narrow Platform with Cover Screw & Mount |
D824PS5NC30112 | Ø3.0mm x L11.5mm, Conical Connection, Narrow Platform with Cover Screw & Mount |
D824PS5NC30102 | Ø3.0mm x L10.0mm, Conical Connection, Narrow Platform with Cover Screw & Mount |
D824PS2NC32162 | Ø3.25mm x L16.0mm, Conical Connection, Narrow Platform with Cover Screw & Mount |
D824PS2NC32132 | Ø3.25mm x L13.0mm, Conical Connection, Narrow Platform with Cover Screw & Mount |
D824PS2NC32112 | Ø3.25mm x L11.0mm, Conical Connection, Narrow Platform with Cover Screw & Mount |
D824PS2NC32102 | Ø3.25mm x L10.0mm, Conical Connection, Narrow Platform with Cover Screw & Mount |