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
00841277111385Novera SeamNVGOP0406NVGOP04062026-10-14
00841277111392Novera SeamNVGOP0410NVAGP0410 / NVAGOP04102026-10-14
00841277111248Novera BalanceNVHYGE025GNVHGE0090 / NVHYGE025G2026-09-04
00841277111286Novera SeamNVPOP1004NVPOP0410 / NVPOP10042026-09-04
00841277111187Novera RenewNVAGAL0202NVAGA0202 / NVAGAL02022026-08-26
10841277111382Novera SeamNVGOP0406NVGOP04062026-10-14
00841277111200Novera RenewNVAGAL0448NVAGA0405 / NVAGAL04482026-08-26
00841277111224Novera RenewNVAGAR0112NVAGR0112 / NVAGAR01122026-08-26
00841277111323Novera RenewNVCHD0448NVCHI0405 / NVCHD04482026-08-26
00841277111378Novera SeamNVGOP0406NVGOP04062026-10-14
00841277111408Novera SeamNVGOP0410NVGOP04102026-10-14
10841277111405Novera SeamNVGOP0410NVGOP04102026-10-14
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

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Primary DI, Brand, Company table
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