| Primary Device ID | 00845384018759 |
| NIH Device Record Key | 1c094402-f5f4-45f3-a834-78cb43af2869 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EG1™ |
| Version Model Number | WIRELESS-HC |
| Catalog Number | WIRELESS-HC |
| Company DUNS | 079116867 |
| Company Name | Anspach Effort, The |
| 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 | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| 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 |
| Phone | +1(800)255-2500 |
| RA-DPYNA-anspachpowe@its.jnj.com | |
| Phone | +1(800)255-2500 |
| RA-DPYNA-anspachpowe@its.jnj.com | |
| Phone | +1(800)255-2500 |
| RA-DPYNA-anspachpowe@its.jnj.com | |
| Phone | +1(800)255-2500 |
| RA-DPYNA-anspachpowe@its.jnj.com | |
| Phone | +1(800)255-2500 |
| RA-DPYNA-anspachpowe@its.jnj.com | |
| Phone | +1(800)255-2500 |
| RA-DPYNA-anspachpowe@its.jnj.com | |
| Phone | +1(800)255-2500 |
| RA-DPYNA-anspachpowe@its.jnj.com | |
| Phone | +1(800)255-2500 |
| RA-DPYNA-anspachpowe@its.jnj.com | |
| Phone | +1(800)255-2500 |
| RA-DPYNA-anspachpowe@its.jnj.com | |
| Phone | +1(800)255-2500 |
| RA-DPYNA-anspachpowe@its.jnj.com | |
| Phone | +1(800)255-2500 |
| RA-DPYNA-anspachpowe@its.jnj.com | |
| Phone | +1(800)255-2500 |
| RA-DPYNA-anspachpowe@its.jnj.com | |
| Phone | +1(800)255-2500 |
| RA-DPYNA-anspachpowe@its.jnj.com | |
| Phone | +1(800)255-2500 |
| RA-DPYNA-anspachpowe@its.jnj.com | |
| Phone | +1(800)255-2500 |
| RA-DPYNA-anspachpowe@its.jnj.com | |
| Phone | +1(800)255-2500 |
| RA-DPYNA-anspachpowe@its.jnj.com | |
| Phone | +1(800)255-2500 |
| RA-DPYNA-anspachpowe@its.jnj.com |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00845384018759 [Primary] |
| ERL | DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00845384018759]
Ethylene Oxide
[00845384018759]
Ethylene Oxide
[00845384018759]
Ethylene Oxide
[00845384018759]
Ethylene Oxide
[00845384018759]
Ethylene Oxide
[00845384018759]
Ethylene Oxide
[00845384018759]
Ethylene Oxide
[00845384018759]
Ethylene Oxide
[00845384018759]
Ethylene Oxide
[00845384018759]
Ethylene Oxide
[00845384018759]
Ethylene Oxide
[00845384018759]
Ethylene Oxide
[00845384018759]
Ethylene Oxide
[00845384018759]
Ethylene Oxide
[00845384018759]
Ethylene Oxide
[00845384018759]
Ethylene Oxide
[00845384018759]
Ethylene Oxide
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-07-18 |
| Device Publish Date | 2022-07-08 |
| 00845384018766 | Receiver for Wireless Hand Control, EG1A |
| 00845384018759 | Wireless Hand Control, EG1A |