Primary Device ID | 00613732114244 |
NIH Device Record Key | 09cb1345-2c98-422b-be56-68389c704b00 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | ROHO ENHANCER Cushion |
Version Model Number | ENH810C |
Company DUNS | 006614792 |
Company Name | Roho, 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 | false |
Serial Number | true |
Manufacturing Date | false |
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 | 00613732114244 [Primary] |
KIC | Cushion, Flotation |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2025-03-24 |
Device Publish Date | 2025-03-15 |
00613732057268 | ENHDEMO |
00613732056810 | ENH1011C |
00613732053338 | ENHMODIFIED |
00613732037314 | ENH1110C |
00613732001148 | ENH99C |
00613732001117 | ENH99DMC |
00613732001094 | ENH98C |
00613732001063 | ENH910C |
00613732001025 | ENH89C |
00613732000974 | ENH88C |
00613732000868 | ENH109C |
00613732000837 | ENH109DMC |
00613732000813 | ENH1010C |
00613732000790 | ENH1010DMC |
00613732000776 | ENHSMC |
00613732000745 | ENHLGC |
00613732000691 | ENHCUSTC |
00613732114268 | ENH1012C |
00613732114244 | ENH810C |
00613732113674 | ENH911C |
00613732113650 | ENH1111C |