FDA.reportPublic FDA data

Novera Renew

Primary DI
00841277111262
Brand
Novera Renew
Company
Harps USA, Inc.
Model
NVCOL0202
Catalog number
NVCOL0202
Device description
Novera Renew Collagen Wound Dressing, 2x2
Published
2026-08-26
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
KGNWound Dressing With Animal-Derived Material(S)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGNWound Dressing With Animal-Derived Material(S)UnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841277111262PrimaryGS10
00841277111255Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841277111262008412771112628412771112620841277111262
00841277111255008412771112558412771112550841277111255

GMDN Terms#

Term, Definition table
TermDefinition
Animal-derived wound matrix dressingA bioabsorbable animal-derived protein matrix [e.g., peptides derived from collagen] designed to provide: 1) a matrix of structural proteins and/or 2) a skin template of living cells [fibroblasts], to facilitate the infiltration/attachment of native cells/tissues (e.g., blood vessels) for wound/skin healing. It is available in various forms [e.g., solution, powder, occlusive/semi-occlusive cover (non-oral)] and may include additional compounds (e.g., alginate, fatty acids). It may be intended to be covered with a secondary dressing. It is commonly intended for treating partial- and full-thickness wounds, ulcers, and draining, surgical, and traumatic wounds. This is a single-use device.

Contacts#

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

Regulatory Flags#

DUNS number
004072158
Device count
10
DM exempt
false
Premarket exempt
false
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
00841277111248Novera BalanceNVHYGE025GNVHYGE025G2026-09-04
00841277111286Novera SeamNVPOP1004NVPOP10042026-09-04
00841277111187Novera RenewNVAGAL0202NVAGAL02022026-08-26
00841277111200Novera RenewNVAGAL0448NVAGAL04482026-08-26
00841277111224Novera RenewNVAGAR0112NVAGAR01122026-08-26
00841277111323Novera RenewNVCHD0448NVCHD04482026-08-26
09001570557278Sempermed Syntegra GreenSGR550SGR5502026-05-21
09001570557308Sempermed Syntegra GreenSGR600SGR6002026-05-21
09001570557339Sempermed Syntegra GreenSGR650SGR6502026-05-21
09001570557360Sempermed Syntegra GreenSGR700SGR7002026-05-21
09001570557391Sempermed Syntegra GreenSGR750SGR7502026-05-21
09001570557421Sempermed Syntegra GreenSGR800SGR8002026-05-21
09001570557452Sempermed Syntegra GreenSGR850SGR8502026-05-21
09001570557483Sempermed Syntegra GreenSGR900SGR9002026-05-21
09001570557797Sempermed Syntegra preCisionSPR550SPR5502026-05-21
09001570557827Sempermed Syntegra preCisionSPR600SPR6002026-05-21
09001570557858Sempermed Syntegra preCisionSPR650SPR6502026-05-21
09001570557889Sempermed Syntegra preCisionSPR700SPR7002026-05-21
09001570557919Sempermed Syntegra preCisionSPR750SPR7502026-05-21
09001570557940Sempermed Syntegra preCisionSPR800SPR8002026-05-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860013117504DermiSphere™ hDRTFesariustherapeutics Inc.KGN2026-09-24
00860013117511DermiSphere™ hDRTFesariustherapeutics Inc.KGN2026-09-24
00850016008190BaseMEMViscus Biologics LLCKGN2026-09-21
00850016008206BaseMEMViscus Biologics LLCKGN2026-09-21
00850016008220BaseMEMViscus Biologics LLCKGN2026-09-21
05694310969468MariGen® CompactKERECIS hf.KGN2026-09-18
05694310969482MariGen® CompactKERECIS hf.KGN2026-09-18
05694310969505MariGen® CompactKERECIS hf.KGN2026-09-18
05694310969529MariGen® CompactKERECIS hf.KGN2026-09-18
05694310969543SurgiClose® CompactKERECIS hf.KGN2026-09-18
05694310969567SurgiClose® CompactKERECIS hf.KGN2026-09-18
05694310969581SurgiClose® CompactKERECIS hf.KGN2026-09-18
05694310969604SurgiClose® CompactKERECIS hf.KGN2026-09-18
00850086458062MaxioCel Chitosan Wound DressingAdvamedica Inc.KGN2026-08-21
00860012016679MaxioCel Chitosan Wound DressingAdvamedica Inc.KGN2026-08-21
00810179632403OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632410OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632427OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632434OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632441OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632458OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632465OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632472OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632595OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632601OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632618OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632625OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632632OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632649OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632656OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31