| Primary Device ID | 20686864048781 |
| NIH Device Record Key | b134f8e0-0274-4266-9044-26838cf194dc |
| Commercial Distribution Discontinuation | 2023-05-30 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | AMD-RITMED SOLON |
| Version Model Number | 52000 |
| Catalog Number | 52000 |
| Company DUNS | 256880576 |
| Company Name | AMD Medicom Inc |
| Device Count | 500 |
| 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 | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Phone | +1(514)636-6262 |
| dabecassis@amdritmed.com | |
| Phone | +1(514)636-6262 |
| dabecassis@amdritmed.com | |
| Phone | +1(514)636-6262 |
| dabecassis@amdritmed.com | |
| Phone | +1(514)636-6262 |
| dabecassis@amdritmed.com | |
| Phone | +1(514)636-6262 |
| dabecassis@amdritmed.com | |
| Phone | +1(514)636-6262 |
| dabecassis@amdritmed.com | |
| Phone | +1(514)636-6262 |
| dabecassis@amdritmed.com | |
| Phone | +1(514)636-6262 |
| dabecassis@amdritmed.com | |
| Phone | +1(514)636-6262 |
| dabecassis@amdritmed.com | |
| Phone | +1(514)636-6262 |
| dabecassis@amdritmed.com | |
| Phone | +1(514)636-6262 |
| dabecassis@amdritmed.com | |
| Phone | +1(514)636-6262 |
| dabecassis@amdritmed.com | |
| Phone | +1(514)636-6262 |
| dabecassis@amdritmed.com | |
| Phone | +1(514)636-6262 |
| dabecassis@amdritmed.com | |
| Phone | +1(514)636-6262 |
| dabecassis@amdritmed.com | |
| Phone | +1(514)636-6262 |
| dabecassis@amdritmed.com |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Room temperature |
| Storage Environment Humidity | Between 0 and 80 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Room temperature |
| Storage Environment Humidity | Between 0 and 80 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Room temperature |
| Storage Environment Humidity | Between 0 and 80 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Room temperature |
| Storage Environment Humidity | Between 0 and 80 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Room temperature |
| Storage Environment Humidity | Between 0 and 80 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Room temperature |
| Storage Environment Humidity | Between 0 and 80 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Room temperature |
| Storage Environment Humidity | Between 0 and 80 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Room temperature |
| Storage Environment Humidity | Between 0 and 80 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Room temperature |
| Storage Environment Humidity | Between 0 and 80 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Room temperature |
| Storage Environment Humidity | Between 0 and 80 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Room temperature |
| Storage Environment Humidity | Between 0 and 80 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Room temperature |
| Storage Environment Humidity | Between 0 and 80 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Room temperature |
| Storage Environment Humidity | Between 0 and 80 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Room temperature |
| Storage Environment Humidity | Between 0 and 80 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Room temperature |
| Storage Environment Humidity | Between 0 and 80 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Room temperature |
| Storage Environment Humidity | Between 0 and 80 Percent (%) Relative Humidity |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00686864048787 [Unit of Use] |
| GS1 | 10686864048784 [Primary] |
| GS1 | 20686864048781 [Package] Contains: 10686864048784 Package: Outer Case [10 Units] Discontinued: 2023-05-30 Not in Commercial Distribution |
| FMA | DEPRESSOR, TONGUE, NON-SURGICAL |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2023-05-31 |
| Device Publish Date | 2019-01-16 |
| 20686864046060 | AMD-RITMED SOLON RAYON TIPPED OB/GYN APPLICATORS 8 Inch |
| 20686864055116 | AMD-RITMED SOLON COTTON TIP APPLICATORS 6 inch |
| 12686864049123 | AMD-RITMED SOLON COTTON TIP APPLICATORS 6 inch |
| 12686864049116 | AMD-RITMED SOLON COTTON TIP APPLICATORS 6 inch |
| 20686864049108 | AMD-RITMED SOLON COTTON TIP APPLICATORS 6 inch |
| 12686864046009 | AMD-RITMED SOLON OB/GYN APPLICATORS 8 Inch |
| 12686864048867 | AMD-RITMED SOLON STANDARD TONGUE DEPRESSORS 6 inch |
| 12686864049086 | AMD-RITMED SOLON COTTON TIP APPLICATORS 6 inch |
| 20686864049078 | AMD-RITMED SOLON COTTON TIP APPLICATORS 6 inch |
| 20686864049061 | AMD-RITMED SOLON COTTON TIP APPLICATORS 6 inch |
| 12686864049055 | AMD-RITMED SOLON COTTON TIP APPLICATORS 3 Inch |
| 20686864049047 | AMD-RITMED SOLON COTTON TIP APPLICATORS 3 Inch |
| 20686864046077 | AMD-RITMED SOLON RAYON TIPPED PROCTOSCOPIC APPLICATORS 16 Inch |
| 20686864046039 | AMD-RITMED SOLON RAYON TIPPED PROCTOSCOPIC APPLICATORS 16 Inch |
| 20686864045995 | AMD-RITMED SOLON RAYON TIPPED OB/GYN APPLICATORS 8 Inch |
| 12686864049178 | AMD-RITMED SOLON INFANT TONGUE DEPRESSORS |
| 20686864048798 | AMD-RITMED SOLON STANDARD TONGUE DEPRESSORS 6 inch |
| 20686864048781 | AMD-RITMED SOLON STANDARD TONGUE DEPRESSORS 6 inch |
| 20686864048873 | AMD-RITMED SOLON - Wooden Applicators - Length 6" |
| 20686864048828 | AMD-RITMED SOLON - Non-Sterile Wooden Spoons, 3" |
| 20686864048651 | AMD-RITMED SOLON INFANT TONGUE DEPRESSORS |