FDA.reportPublic FDA data

Novera Cloud

Primary DI
00841277111064
Brand
Novera Cloud
Company
Harps USA, Inc.
Model
NVSFS0909 / NVSFO9292
Catalog number
NVSFS0909 / NVSFO9292
Device description
Silicone Foam Dressing with Border Sacrum 9.2x 9.2
Published
2026-10-30
Public version status
New
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NACDressing, Wound, Hydrophilic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NACDressing, Wound, HydrophilicGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841277111064PrimaryGS10
00841277111057Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841277111064008412771110648412771110640841277111064
00841277111057008412771110578412771110570841277111057

Contacts#

Phone, Email table
PhoneEmail
800-366-9545Glove.Info@SempermedUSA.com

Regulatory Flags#

DUNS number
004072158
Device count
10
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841277110951Novera CloudNVSFB0404 / NVSFOB0404NVSFB0404 / NVSFOB04042026-10-30
00841277110975Novera CloudNVSFB0606 / NVSFOB0606NVSFB0606 / NVSFOB06062026-10-30
00841277111002Novera CloudNVSFO0404NVSFO04042026-10-30
00841277111026Novera CloudNVSFO0606NVSFO06062026-10-30
00841277111040Novera CloudNVSFS0707 / NVSFO0707NVSFS0707 / NVSFO07072026-10-30
00841277111088Novera CloudNVSFB0303 / NVSFOB0303NVSFB0303 / NVSFOB03032026-10-30
00841277111101Novera BreezeNVHMF0203 / NVFLM2228NVHMF0203 / NVFLM22282026-10-30
00841277111125Novera BreezeNVHMF0405 / NVFLM0447NVHMF0405 / NVFLM04472026-10-30
00841277111149Novera BreezeNVHMR0203 / NVFLMR2228NVHMR0203 / NVFLMR22282026-10-30
00841277111163Novera BreezeNVHMR0405 / NVFLMR0447NVHMR0405 / NVFLMR04472026-10-30
00841277111309Novera SeamNVPOP0205 / NVPOP2405NVPOP0205 / NVPOP24052026-10-30
00841277111347Novera LockNVCHI0405 / NVCHD0448NVCHI0405 / NVCHD04482026-10-30
00841277111361Novera RenewNVAGA0606 / NVAGAL0606NVAGA0606 / NVAGAL06062026-10-30
00841277111385Novera SeamNVGOP0406NVGOP04062026-10-14
00841277111187Novera RenewNVAGAL0202NVAGA0202 / NVAGAL02022026-08-26
00841277111392Novera SeamNVGOP0410NVAGP0410 / NVAGOP04102026-10-14
00841277111248Novera BalanceNVHYGE025GNVHGE0090 / NVHYGE025G2026-09-04
00841277111286Novera SeamNVPOP1004NVPOP0410 / NVPOP10042026-09-04
10841277111382Novera SeamNVGOP0406NVGOP04062026-10-14
00841277111200Novera RenewNVAGAL0448NVAGA0405 / NVAGAL04482026-08-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00050428135563CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNAC2026-10-31
00050428135570CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNAC2026-10-31
00050428135587CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNAC2026-10-31
00841277110951Novera CloudHarps USA, Inc.NAC2026-10-30
00841277110975Novera CloudHarps USA, Inc.NAC2026-10-30
00841277111002Novera CloudHarps USA, Inc.NAC2026-10-30
00841277111026Novera CloudHarps USA, Inc.NAC2026-10-30
00841277111040Novera CloudHarps USA, Inc.NAC2026-10-30
00841277111088Novera CloudHarps USA, Inc.NAC2026-10-30
00841277111309Novera SeamHarps USA, Inc.NAC2026-10-30
00841277111347Novera LockHarps USA, Inc.NAC2026-10-30
10884389112090MEDLINEMEDLINE INDUSTRIES, INC.NAC2026-10-09
10884389931967MEDLINEMEDLINE INDUSTRIES, INC.NAC2026-10-09
00810173051996EVERLIT CAREEverlit Global Inc.NAC2026-10-07
04052199807188Zetuvit PlusPAUL HARTMANN AGNAC2026-09-28
04260223630224curea P1curea medical GmbHNAC2026-09-27
04260223630231curea P1curea medical GmbHNAC2026-09-27
04260223630248curea P1curea medical GmbHNAC2026-09-27
04260223630255curea P1curea medical GmbHNAC2026-09-27
04260223630262curea P1curea medical GmbHNAC2026-09-27
04260223630279curea P1curea medical GmbHNAC2026-09-27
04260223630286curea P1 draincurea medical GmbHNAC2026-09-27
04260223630347curea P2curea medical GmbHNAC2026-09-27
04260223630378curea P2curea medical GmbHNAC2026-09-27
04260223630408curea P2curea medical GmbHNAC2026-09-27
04260223630422curea P2curea medical GmbHNAC2026-09-27
04260223630651curea P1curea medical GmbHNAC2026-09-27
04260223630668curea P2curea medical GmbHNAC2026-09-27
04260223630736curea P1curea medical GmbHNAC2026-09-27
04260223630880curea P1curea medical GmbHNAC2026-09-27