| Primary Device ID | D066PGBCL2 |
| NIH Device Record Key | 2f927c00-0990-4990-a4fa-4d0251f0fe26 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PlastCare |
| Version Model Number | PG-BCL |
| Catalog Number | PG-BCL |
| Company DUNS | 129529337 |
| Company Name | Proguard Health, Inc |
| Device Count | 100 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | MR Safe |
| 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 | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D066PGBCL0 [Unit of Use] |
| HIBCC | D066PGBCL1 [Primary] |
| HIBCC | D066PGBCL2 [Package] Contains: D066PGBCL1 Package: [10 Units] In Commercial Distribution |
| DYN | Mouthpiece, Saliva Ejector |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-07-12 |
| Device Publish Date | 2021-07-02 |
| D066PGWHW2 | Saliva Ejector White With White Tip |
| D066PGSTRSS25102 | Syringe Sleeves with Pre-Cut Opening (2-1/2" x 10") |
| D066PGSTRS81832 | X-Ray Sensor Sleeves (8" x 1-5/8") |
| D066PGSTRS81252 | X-Ray Sensor Sleeves (8" x 1-3/8") |
| D066PGSTRS27242 | Half Chair Sleeves (27-1/2" x 24") |
| D066PGSTRS25102 | Digital X-Ray Sensor Sleeves (2-1/2" x 10") |
| D066PGSTRS15262 | X-Ray Head Sleeves (15" x 26") |
| D066PGSTRS11162 | Tray Sleeves (11-5/8" x 16") |
| D066PGSTRS105142 | Tray Sleeves (10-1/2" x 14") |
| D066PGSTRS10142 | Headrest Covers Sleeves (10" x 14") |
| D066PGSTRS10112 | Headrest Covers Sleeves (10" x 11") |
| D066PGSTA003B1 | Surgical Aspirator Tips Small Vented 1/16" Diam (Blue) |
| D066PGSTA002G1 | Surgical Aspirator Tips Large Vented 1/4" Diam (Green) |
| D066PGSTA001W1 | Surgical Aspirator Tips Medium Vented 1/8" Diam (White) |
| D066PGSIDEW2 | Bite Registration Tray Sideless (White) |
| D066PGS3CC30GKIT2 | Irrigation Needle With Half Cutting Tips: 30Cc Syringe + 30G |
| D066PGS3CC27GKIT2 | Irrigation Needle With Half Cutting Tips: 3Cc Syringe + 27G |
| D066PGS3CC25GKIT2 | Irrigation Needle With Half Cutting Tips: 3Cc Syringe + 25G |
| D066PGS12CC2 | Irrigation Needle With Half Cutting Tips Utility Syringe 12 Cc |
| D066PGQUADY2 | Bite Registration Tray Quadrant (Yellow) |
| D066PGPOSTG2 | Bite Registration Tray Posterior Classic Short (Green ) |
| D066PGPOSTB0 | Bite Registration Tray Posterior (Blue) |
| D066PGPNK2 | Saliva Ejector Pink With Pink Tip |
| D066PGPCL2 | Saliva Ejector Purple With Clear Tip |
| D066PGNEEDLE30GXS42 | Anesthetic Dental Needles 30G/X-Short, 0.3mm x 12 mm (Blue) |
| D066PGNEEDLE30GS42 | Anesthetic Dental Needles 30G/Short, 0.3mm x 21 mm (Blue) |
| D066PGNEEDLE27GS40 | Anesthetic Dental Needles 27G/SHORT, 0.4mm x 30mm (Yellow) |
| D066PGNEEDLE27GL42 | Anesthetic Dental Needles 27G/Long, 0.4mm x 30mm (Yellow) |
| D066PGMBL32 | Ear-Loop Mask Blue (Level 3) |
| D066PGMBL22 | Ear-Loop Mask Blue (Level 2) |
| D066PGMBL12 | Ear-Loop Mask Blue (Level 1) |
| D066PGMBK32 | Ear-Loop Mask Black (Level 3) |
| D066PGMBK22 | Ear-Loop Mask Black (Level 2) |
| D066PGMBK12 | Ear-Loop Mask Black (Level 1) |
| D066PGMA11030 | Micro Applicators Regular (Purple) |
| D066PGMA11022 | Micro Applicators Regular (Orange) |
| D066PGMA11010 | Micro Applicators Regular (Green) |
| D066PGMA11002 | Micro Applicators Regular (Blue) |
| D066PGMA10022 | Micro Applicators Fine (Yellow) |
| D066PGMA10012 | Micro Applicators Fine (Mauve) |
| D066PGMA10002 | Micro Applicators Superfine (White) |
| D066PGHVE022 | Vented Evacuation Tips Rainbow |
| D066PGHVE012 | Vented Evacuation Tips White |
| D066PGG41002 | Silicone Dispenser Gun 4:1 & 10:1 |
| D066PGG11002 | Silicone Dispenser Gun 1:1 & 2:1 |
| D066PGFULLAP2 | Bite Registration Tray Full Arch (Pink) |
| D066PGFT272 | Pre-bent Flow Dispensing Tips 27G (Gray) |
| D066PGFT250 | Pre-bent Flow Dispensing Tips 25G (Orange) |
| D066PGFT230 | Pre-bent Flow Dispensing Tips 23G (Blue) |
| D066PGFT210 | Pre-bent Flow Dispensing Tips 21G (Green) |