| Primary Device ID | 00817800020578 |
| NIH Device Record Key | 63c4af35-04b2-4606-b02f-ba30eb2290c5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GPS |
| Version Model Number | 45-5012 |
| Company DUNS | 968188644 |
| Company Name | GROUP PRACTICE SOLUTIONS INC. |
| Device Count | 1 |
| DM Exempt | false |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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 |
|---|---|
| GS1 | 00817800020578 [Primary] |
| FME | Gown, Examination |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-12-05 |
| 00817800020752 | TEMPORARY CEMENT DUAL-BARREL SYRINGE NON-EUGENOL 6GM |
| 00817800020660 | ETCH GEL 37% 1.2ML SYRINGE 4/BX |
| 00817800020653 | BARRIER ENVELOPES SIZE 2 |
| 00817800020646 | BARRIER ENVELOPES SIZE 1 |
| 00817800020639 | DISPOSABLE LAB COAT - XX-LARGE |
| 00817800020622 | DISPOSABLE LAB COAT - X-LARGE |
| 00817800020615 | DISPOSABLE LAB COAT - LARGE |
| 00817800020608 | DISPOSABLE LAB COAT - MEDIUM |
| 00817800020592 | DISPOSABLE LAB COAT - SMALL |
| 00817800020585 | DISPOSABLE GOWNS TIE-BACK LARGE |
| 00817800020578 | DISPOSABLE GOWNS TIE-BACK MEDIUM |
| 00817800020561 | STERI-TUBING 6'' W/INDICATOR |
| 00817800020554 | STERI-TUBING 4'' W/INDICATOR |
| 00817800020547 | STERI-TUBING 3'' W/INDICATOR |
| 00817800020530 | STERI-TUBING 2'' W/INDICATOR |
| 00817800020523 | PLEATED MASK W/ SHIELD EAR-LOOP BLUE |
| 00817800020516 | PLEATED DUAL-FIT LEVEL 1 WHITE |
| 00817800020509 | PLEATED DUAL-FIT LEVEL 1 PINK |
| 00817800020493 | PLEATED DUAL-FIT LEVEL 1 BLUE |
| 00817800020486 | BITE REG. ''HARD'' FAST-SET 2 CART. W/TIPS |
| 00817800020479 | BARRIER ENVELOPES SIZE 0 |
| 90817800020427 | BITE REG. SUPER FAST-SET MINT CC 2 CART. W/TIPS |
| 90817800020410 | BITE REG. FAST-SET MINT CC 2 CART. W/TIPS |
| 90817800020403 | BITE REG. SUPER FAST-SET 2 CART. W/TIPS |
| 90817800020397 | BITE REG. FAST-SET W/TIPS |
| 90817800020380 | BITE REG. REG-SET W/TIPS |
| 90817800020366 | PREMIUM MOLDED MASK PINK |
| 90817800020342 | PREMIUM MOLDED MASK BLUE |
| 90817800020328 | DIFFUSER EAR-LOOP MASK PINK |
| 90817800020304 | DIFFUSER EAR-LOOP MASK BLUE |
| 90817800020281 | BREATHE EZ EAR-LOOP PINK |
| 90817800020267 | BREATH-EZ PLEATED MASK BLUE |
| 90817800020243 | STERI-POUCHES DEFEND+ 13'' X 20'' |
| 90817800020229 | STERI-POUCHES DEFEND+ 9'' X 15'' |
| 90817800020205 | STERI-POUCHES DEFEND+ 7 1/2'' X 13'' |
| 90817800020182 | STERI-POUCHES DEFEND+ 5 1/4'' X 10'' |
| 90817800020168 | STERI-POUCHES DEFEND+ 3 1/2'' X 10'' |
| 90817800020144 | STERI-POUCHES DEFEND+ 3 1/2'' X 10'' |
| 90817800020120 | STERI-POUCHES DEFEND+ 3 1/2'' X 5 1/4'' |
| 90817800020106 | STERI-POUCHES DEFEND+ 2 3/4'' X 10'' |
| 90817800020083 | STERI-POUCHES DEFEND+ 2'' X 7 3/4'' |
| 90817800020069 | STERI-POUCHES DEFEND+ 2 1/4'' X 2 2/3'' |
| 90817800020045 | STERI-POUCHES DEFEND+ 2.25'' X 4'' |
| 90817800020038 | AUTOCLAVE IND. TAPE 1'' |
| 90817800020021 | AUTOCLAVE IND. TAPE 3/4'' |
| 90817800020014 | AUTOCLAVE IND. TAPE 1/2'' |