| Primary Device ID | 04009408027011 | 
| NIH Device Record Key | 9e5b6e9e-7716-4731-bce7-04974146e6b4 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Caroli | 
| Version Model Number | extra | 
| Company DUNS | 316433234 | 
| Company Name | Curatex GmbH | 
| Device Count | 1 | 
| DM Exempt | true | 
| 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 | false | 
| Serial Number | false | 
| 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 | true | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 04000576083397 [Package] Package: [12 Units] In Commercial Distribution | 
| GS1 | 04009408027011 [Primary] | 
| EYQ | Garment, Protective, For Incontinence | 
| Steralize Prior To Use | false | 
| Device Is Sterile | false | 
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2020-09-16 | 
| Device Publish Date | 2020-09-08 | 
| 04009408027158 | Caroli Incontinence Underwear Super Extra Large (XXL) | 
| 04009408027141 | Caroli Incontinence Underwear Super Extra Large (XL) | 
| 04009408027134 | Caroli Incontinence Underwear Large Premium Couture | 
| 04009408027127 | Caroli Incontinence Underwear Large Premium Discreet | 
| 04009408027110 | Caroli Incontinence Underwear Large Protect + Care | 
| 04009408027097 | Caroli Incontinence Underwear Medium Premium Discreet | 
| 04009408027080 | Caroli Incontinence Underwear Medium Protect + Care | 
| 04009408027066 | Caroli incontinence pads maxi plus | 
| 04009408027042 | Caroli incontinence pads mini plus | 
| 04009408027035 | Caroli incontinence pads extra plus | 
| 04009408027011 | Caroli incontinence pads extra | 
| 04009408026991 | Caroli incontinence pads normal | 
| 04009408026953 | Caroli incontinence pantyliners ultra mini plus | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  CAROLI  88946366  not registered Live/Pending | W. Pelz GmbH & Co. 2020-06-03 | 
|  CAROLI  79272544  not registered Live/Pending | W. Pelz GmbH & Co. 2019-06-17 | 
|  CAROLI  79068068  3712336 Live/Registered | CAROLI STEFANO Ditta Individuale 2009-01-26 | 
|  CAROLI  75697357  2368264 Dead/Cancelled | Caroli, Stefano 1999-03-22 | 
|  CAROLI  75457648  not registered Dead/Abandoned | Stefano Caroli 1998-03-26 |