| Primary Device ID | H66805007480 |
| NIH Device Record Key | 494fa0d7-d7c5-4802-b40a-04cdb84f7104 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Prehma |
| Version Model Number | 05-00748 |
| Catalog Number | 05-00748 |
| Company DUNS | 073503117 |
| Company Name | Keystone Industries |
| Device Count | 10 |
| DM Exempt | true |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| 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 | true |
| OTC Over-The-Counter | false |
| Phone | +1(800)333-3131 |
| tschwear@keystoneind.com | |
| Phone | +1(800)333-3131 |
| tschwear@keystoneind.com | |
| Phone | +1(800)333-3131 |
| tschwear@keystoneind.com | |
| Phone | +1(800)333-3131 |
| tschwear@keystoneind.com | |
| Phone | +1(800)333-3131 |
| tschwear@keystoneind.com | |
| Phone | +1(800)333-3131 |
| tschwear@keystoneind.com | |
| Phone | +1(800)333-3131 |
| tschwear@keystoneind.com | |
| Phone | +1(800)333-3131 |
| tschwear@keystoneind.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | H66805007480 [Unit of Use] |
| HIBCC | H66805007481 [Primary] |
| EJL | BUR, DENTAL |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[H66805007480]
Moist Heat or Steam Sterilization
[H66805007480]
Moist Heat or Steam Sterilization
[H66805007480]
Moist Heat or Steam Sterilization
[H66805007480]
Moist Heat or Steam Sterilization
[H66805007480]
Moist Heat or Steam Sterilization
[H66805007480]
Moist Heat or Steam Sterilization
[H66805007480]
Moist Heat or Steam Sterilization
[H66805007480]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-12-08 |
| Device Publish Date | 2022-11-30 |
| H66810186101 | Optima Ear Loop Procedural Masks Pink |
| H66810185101 | Surgical Tie-On Masks Blue |
| H66810184101 | Optima Ear Loop Procedural Masks Green |
| H66810182101 | Procedural Ear Loop Masks Green |
| H66810180101 | Procedural Ear Loop Masks Blue |
| H66810171101 | Surgical Cone Masks Pink |
| H66810170101 | Surgical Cone Masks Blue |
| H66879020000 | Prehma Saliva Ejectors Wht/Wht Tip Case 10/100 |
| H66870039990 | Prehma D3 HVE Tips White Bag/50 |
| H66836011220 | Mylar strips (Tube x 1000) |
| H66836010220 | Mylar Strips (Tube X 100) |
| H66827013100 | SURGICAL BLADES CS #25 ( BX X 100 ) |
| H66827011100 | SURGICAL BLADES CS #24 ( BX X 100 ) |
| H66827007100 | SURGICAL BLADES CS #20 ( BX X 100 ) |
| H66827005100 | SURGICAL BLADES CS #15 ( BX X 100 ) |
| H66827003100 | SURGICAL BLADES CS #12 ( BX X 100 ) |
| H66827002100 | SURGICAL BLADES CS #11 ( BX X 100 ) |
| H66827001100 | SURGICAL BLADES CS #10 ( BX X 100 ) |
| H66819022121 | MATRIX RETAINER CHILD ( EA ) |
| H66819021121 | MATRIX RETAINER ADULT ( EA ) |
| H66819020121 | MATRIX RETAINER UNIV ( EA ) |
| H66819008120 | MATRIX BAND #13 0.015 ( BAG X 12 ) |
| H66819007120 | MATRIX BAND #3 0.015 ( BAG X 12 ) |
| H66819006120 | MATRIX BAND #2 0.015 ( BAG X 12 ) |
| H66819005120 | MATRIX BAND #1 0.015 ( BAG X 12 ) |
| H66819004120 | MATRIX T-BAND LG X100 ( BAG X 100 ) |
| H66819003120 | MATRIX T-BAND SM X100 ( BAG X 100 ) |
| H66819002121 | MATRIX ROLL 1/4 0.015 ( BX X 10FT ) |
| H66819001121 | MATRIX ROLL 3/16 0.015 ( BX X 10FT ) |
| H66812012100 | PREHMA SURGICAL ASPIRATOR 1/16 ( BAG X 25) |
| H66812011100 | PREHMA SURGICAL ASPIRATOR 1/8 ( BAG X 25) |
| H66812010100 | PREHMA SURGICAL ASPIRATOR 1/4 ( BAG X 25) |
| H66812002100 | PREHMA SALIVA EJECTORS WHITE BAG X 100 |
| H66812001100 | PREHMA SALIVA EJECTORS CLEAR BAG X 100 |
| H66810053100 | SYRINGE SLEEVE CLEAR (BX X 500)- Barrier Item |
| H66810052100 | SYRINGE SLEEVE BLUE (BX X 500)- Barrier Item |
| H66810051100 | BARRIER FILM BLUE (BX X 1200) |
| H66810050100 | BARRIER FILM CLEAR (BX X 1200) |
| H66810047100 | Disposable Air/Water SyringeTips Assorted (250/bag) |
| H66810045100 | Disposable Air/Water Syringe Tips White (250/bag) |
| H66805816480 | CARBIDE BUR PREHMA FG 8 100 PK |
| H66805813480 | Carbide Bur Prehma FG 330 100 PK |
| H66805811480 | CARBIDE BUR PREHMA FG 245 100 PK |
| H66805805480 | CARBIDE BUR PREHMA FG 556 100 PK |
| H66805804480 | CARBIDE BUR PREHMA LA 4 100 PK |
| H66805678480 | CARBIDE BUR PREHMA SC 199Z 10 PK |
| H66805646480 | CARBIDE BUR PREHMA LA 8 10 PK |
| H66805638480 | CARBIDE BUR PREHMA LA 700 10 PK |
| H66805635480 | CARBIDE BUR PREHMA LA 6 10 PK |
| H66805628480 | CARBIDE BUR PREHMA LA 557 10 PK |