| Primary Device ID | 00840018667969 |
| NIH Device Record Key | 1db19d0e-6a98-4ba0-8124-d5176e58e77a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Nordent Manufacturing, Inc. |
| Version Model Number | RENSGRA7-8 |
| Catalog Number | Nordent Catalog Hygiene section |
| Company DUNS | 053187985 |
| Company Name | NORDENT MANUFACTURING 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 | false |
| 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 | true |
| OTC Over-The-Counter | true |
| Phone | 8474374780 |
| ashah@nordent.com | |
| Phone | 8474374780 |
| ashah@nordent.com | |
| Phone | 8474374780 |
| ashah@nordent.com | |
| Phone | 8474374780 |
| ashah@nordent.com | |
| Phone | 8474374780 |
| ashah@nordent.com | |
| Phone | 8474374780 |
| ashah@nordent.com | |
| Phone | 8474374780 |
| ashah@nordent.com | |
| Phone | 8474374780 |
| ashah@nordent.com | |
| Phone | 8474374780 |
| ashah@nordent.com | |
| Phone | 8474374780 |
| ashah@nordent.com | |
| Phone | 8474374780 |
| ashah@nordent.com | |
| Phone | 8474374780 |
| ashah@nordent.com | |
| Phone | 8474374780 |
| ashah@nordent.com |
| Atherectomy Cutter Length | 14 Inch |
| Atherectomy Cutter Length | 14 Inch |
| Atherectomy Cutter Length | 14 Inch |
| Atherectomy Cutter Length | 14 Inch |
| Atherectomy Cutter Length | 14 Inch |
| Atherectomy Cutter Length | 14 Inch |
| Atherectomy Cutter Length | 14 Inch |
| Atherectomy Cutter Length | 14 Inch |
| Atherectomy Cutter Length | 14 Inch |
| Atherectomy Cutter Length | 14 Inch |
| Atherectomy Cutter Length | 14 Inch |
| Atherectomy Cutter Length | 14 Inch |
| Handling Environment Humidity | Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 350 Degrees Fahrenheit |
| Storage Environment Temperature | Between 65 Degrees Fahrenheit and 75 Degrees Fahrenheit |
| Handling Environment Humidity | Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 350 Degrees Fahrenheit |
| Storage Environment Temperature | Between 65 Degrees Fahrenheit and 75 Degrees Fahrenheit |
| Handling Environment Humidity | Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 350 Degrees Fahrenheit |
| Storage Environment Temperature | Between 65 Degrees Fahrenheit and 75 Degrees Fahrenheit |
| Handling Environment Humidity | Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 350 Degrees Fahrenheit |
| Storage Environment Temperature | Between 65 Degrees Fahrenheit and 75 Degrees Fahrenheit |
| Handling Environment Humidity | Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 350 Degrees Fahrenheit |
| Storage Environment Temperature | Between 65 Degrees Fahrenheit and 75 Degrees Fahrenheit |
| Handling Environment Humidity | Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 350 Degrees Fahrenheit |
| Storage Environment Temperature | Between 65 Degrees Fahrenheit and 75 Degrees Fahrenheit |
| Handling Environment Humidity | Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 350 Degrees Fahrenheit |
| Storage Environment Temperature | Between 65 Degrees Fahrenheit and 75 Degrees Fahrenheit |
| Handling Environment Humidity | Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 350 Degrees Fahrenheit |
| Storage Environment Temperature | Between 65 Degrees Fahrenheit and 75 Degrees Fahrenheit |
| Handling Environment Humidity | Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 350 Degrees Fahrenheit |
| Storage Environment Temperature | Between 65 Degrees Fahrenheit and 75 Degrees Fahrenheit |
| Handling Environment Humidity | Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 350 Degrees Fahrenheit |
| Storage Environment Temperature | Between 65 Degrees Fahrenheit and 75 Degrees Fahrenheit |
| Handling Environment Humidity | Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 350 Degrees Fahrenheit |
| Storage Environment Temperature | Between 65 Degrees Fahrenheit and 75 Degrees Fahrenheit |
| Handling Environment Humidity | Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 350 Degrees Fahrenheit |
| Storage Environment Temperature | Between 65 Degrees Fahrenheit and 75 Degrees Fahrenheit |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840018667969 [Primary] |
| EMS | Curette, Periodontic |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00840018667969]
Moist Heat or Steam Sterilization
[00840018667969]
Moist Heat or Steam Sterilization
[00840018667969]
Moist Heat or Steam Sterilization
[00840018667969]
Moist Heat or Steam Sterilization
[00840018667969]
Moist Heat or Steam Sterilization
[00840018667969]
Moist Heat or Steam Sterilization
[00840018667969]
Moist Heat or Steam Sterilization
[00840018667969]
Moist Heat or Steam Sterilization
[00840018667969]
Moist Heat or Steam Sterilization
[00840018667969]
Moist Heat or Steam Sterilization
[00840018667969]
Moist Heat or Steam Sterilization
[00840018667969]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-01-05 |
| Device Publish Date | 2025-12-26 |
| 00840018667983 | RESCGRA11-12 |
| 00840018667976 | Xdura, Curette, DE, Gracey #9-10, DuraLite® Round Handle |
| 00840018667969 | Xdura, Curette, DE, Gracey #7-8, DuraLite® Round Handle |
| 00840018667952 | Xdura, Curette, DE, Gracey #7-8 Long Reach, DuraLite® Round Handle |
| 00840018667945 | Xdura, Curette, DE, Gracey #5-6, DuraLite® Round Handle |
| 00840018667938 | Xdura, Curette, DE, Gracey #3-4, DuraLite® Round Handle |
| 00840018667921 | Xdura, Curette, DE, Gracey #15-16, DuraLite® Round Handle |
| 00840018667914 | Xdura, Curette, DE, Gracey #13-14, DuraLite® Round Handle |
| 00840018667907 | Xdura, Curette, DE, Gracey #13-14 Long Reach, DuraLite® Round Handle |
| 00840018667891 | Xdura, Curette, DE, Gracey #1-2, DuraLite® Round Handle |
| 00840018667884 | Xdura, Curette, DE, Gracey #12-13, DuraLite® Round Handle |
| 00840018667877 | Xdura, Curette, DE, Gracey #11-14, DuraLite® Round Handle |
| 00840018667860 | RENSGRA11-12 |
| 00840018667853 | Xdura, Curette, DE, Gracey #11-12 Long Reach, DuraLite® Round Handle |
| 00840018667839 | Classic, Curette, DE, Gracey #9-10, O Style, Medium Round Handle |
| 00840018667822 | Classic, Curette, DE, Gracey #15-16, O Style, Medium Round Handle |
| 00840018667815 | Classic, Curette, DE, Gracey #13-14 Long Reach, O Style, Medium Round Handle |
| 00840018667808 | Classic, Curette, DE, Gracey #1-2, O Style, Medium Round Handle |
| 00840018667785 | Classic, Curette, DE, Gracey #12-13, O Style, DuraLite® Round Handle |
| 00840018667778 | Classic, Curette, DE, Gracey #11-14, O Style, DuraLite® Round Handle |
| 00840018667754 | Xdura, Curetter, DE, Gracey #9-10, O Style, Durite Round Handle |
| 00840018667730 | XDURA, Curette, DE, Gracey # 1-2, O Style, DuraliteRound Handle |
| 00840018667723 | Xdura, Curette, DE, Gracey #12-13, O Style, DuraLite® Round Handle |
| 00840018667716 | Curette, DE, Gracey #11-14, O Style, DuraLite® Round Handle |
| 00840018667686 | CURETTE, DE, GRACEY #9-10 O STYLE, DURALITE ROUND HANDLE |
| 00840018667563 | Curette, DE,Xdura,Trade, Univ of CA 3-4, Duralite ColorRings Handle |
| 00840018667532 | Curette, DE,Gracey #15-16, Old Style, DXDURA Round Handle |
| 00840018667471 | Curette, DE, Gracey #11-12, Long OLD STYLE, XDURA ROUND Handle |
| 00840018667433 | Curette, DE, Gracey #11-12, Long OLD STYLE, XDURA ROUND Handle |
| 00840018667426 | Curette, DE, Gracey #13-14, Long Old Style, XDURA RUND Handle |
| 00840018667419 | Curette, DE, Gracey #17-18,Old Style, XDURA Round Handle |
| 00840018667402 | Curette, DE, Gracey #5-6, Old Style, XDURA Round Handle |
| 00840018667136 | Curette, DE, University of California Ratcliff #3-4 |
| 00840018667112 | " XDURA CURETTE DE GRACEY #5-6 DL CC, OLD STYLE" |
| 00840018667105 | CURETTE, DE, GRACEY #7-8, OLD STYLE, XDURA ROUND HANDLE |
| 00840018667099 | CURETTE, DE, GRACEY #3-4, OLD STYLE, XDURA ROUND HANDLE |
| 00840018666863 | XDURA CURETTE DE GRACEY #1-2 DL CC, OLD STYLE |
| 00840018666856 | XDURA CURETTE DE GRACEY #13-14 LONG SHANK DL CC, OLD STYLE |
| 00840018666849 | XDURA CURETTE DE GRACEY #11-12 LONG SHANK DL CC, OLD STYLE |
| 00840018666832 | XDURA CURETTE DE GRACEY #1-2 LONG SHANK DL CC, OLD STYLE |
| 00840018666504 | RENSGR3-4L |
| 00840018666467 | CURETTE, DE, GRACEY #13-14, OLD STYLE, XDURA ROUND HANDLE |
| 00840018665743 | XDURA CURETTE DE GRACEY #5-6 LONG |
| 00840018663664 | Curette, DE, Xdura, Trade, Gracey #15-16 Mini Blade / Long Reach |
| 00840018663619 | Curette, DE, Xdura, Gracey #15-16 Mini Blade, DuraLite Round Handle |
| 00840018663602 | Curette, DE, Xdura, Gracey #17-18 Mini Blade, DuraLite Round Handle |