Duns Number:961027315
Device Description: Maxi PadCurity5.51 x 13.78 in. (14.0 x 35.0 cm)HeavyContouredUnscentedEN - Maxi Pad5.51 x Maxi PadCurity5.51 x 13.78 in. (14.0 x 35.0 cm)HeavyContouredUnscentedEN - Maxi Pad5.51 x 13.78 in. (14.0 x 35.0 cm)Materials of fabrication: Topsheet (skin contact): is a polypropylene film.Acquistion Distribution Layer: is a nonwoven highloft layer made of polyester.Absorbent Core: cellulose fibers with a super absorbent polymer.Backsheet (external layer): is a nonwoven made of polyethylene.Includes a release siliconed paper and polyolefin adhesives in the seams and joints.FR - Maxi Pad5.51 x 13.78 in. (14.0 x 35.0 cm)Lourd - Découpe anatomique -Non-parfuméMatériaux de fabrication: Voile intérieur (contact avec la peau): est polypropylene.Voile d'acquisition est highloft en polyester.Corps absorbant: fibre cellulose avec polyacrylate de sodium.Enveloppe extérieur (voile exterieur): est polyethylene.Inclus un papier silicone et des adhéstifs polyoléfiniques dans les countures et les joints.ES - Maxi Pad5.51 x 13.78 in. (14.0 x 35.0 cm)Severo -Contorneado -Sin perfumeMateriales de fabricación: Cubierta superior (en contacto con la piel): es una película de polipropileno.Cubierta de adquisición y distribución: es una cubierta highloft hecha de polyester.Núcleo absorbente: fibras de celulosa con un polímero super absorbente.Lámina posterior (cubierta externa): es una cubierta de polietileno.Incluye papel siliconado y adhesive de poliolefinas con el que se unen todos los materiales.
Catalog Number
FH-PADPCH3
Brand Name
Curity
Version/Model Number
FH-PADPCH3
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
Yes
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HHD
Product Code Name
Pad, menstrual, unscented
Public Device Record Key
46df3ab0-064b-4b3f-b310-fb746980e1e8
Public Version Date
April 19, 2021
Public Version Number
1
DI Record Publish Date
April 09, 2021
Package DI Number
50885380173347
Quantity per Package
8
Contains DI Package
20885380173346
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 101686 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 139430 |
| 3 | A medical device with high risk that requires premarket approval | 8 |
| U | Unclassified | 40 |