FDA.reportPublic FDA data

VERIS

Primary DI
00612553000187
Brand
VERIS
Company
HARTMANN USA, INC.
Model
906012 2X2 sheet 15/BX
Catalog number
906012
Device description
VERIS 2X2 sheet 15/BX
Published
2026-10-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FRODressing, Wound, Drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRODressing, Wound, DrugUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K222143000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222143000APIS (R), VERIS (TM)Sweetbio, Inc.2023-10-13FRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00612553000187PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00612553000187006125530001876125530001870612553000187

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature00

Regulatory Flags#

DUNS number
010137511
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00612553000163VERIS906010 0.6X0.6 sheet 15/BX9060102026-10-01
00612553000170VERIS906011 1X1 sheet 15/BX9060112026-10-01
00612553000194VERIS906013 0.3X8/3 strip 15/BX9060132026-10-01
30612553024290COLACTIVE PLUS 7x7 10/BX103500002020-09-01
04052199578729ColActive Plus Powder Ag Wound Filler101600022021-08-27
04052199578750ColActive Plus Powder Wound Filler101600012021-08-27
30612553024276ColActive Plus 2x2101600002020-09-01
30612553024283ColActive Plus 4x4101800002020-09-01
30612553024306ColActive Plus AG 2x2 600/cs103300002020-09-01
30612553024313ColActive Plus AG 4x4 300/cs103400002020-09-01
30612553024320COLACTIVE PLUS AG 7x7 10/BX103200002020-09-01
10612553018073Sorbalgon Ag st 2g/30cm P59996092020-09-01
10612553018080Sorbalgon Ag st 15x15cm P59996102020-09-01
10612553018103Sorbalgon Ag st 5x5cm P109996122020-09-01
10612553023480PROXIMEL AG SILICONE DRESSING 3x3 10/BX151000002020-09-01
10612553023497PROXIMEL AG SILICONE DRESSING 4x4 10/BX152000002020-09-01
10612553023503PROXIMEL AG SILICONE DRESSING 6x6 5/BX153000002020-09-01
10612553023510PROXIMEL AG SILICONE DRESSING 4x12 5/BX154000002020-09-01
10612553023527PROXIMEL AG DRESSING SM SACRAL 5/BX155000002020-09-01
10612553018097Sorbalgon Ag st 10x10cm P109996112020-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00612553000163VERISHARTMANN USA, INC.FRO2026-10-01
00612553000170VERISHARTMANN USA, INC.FRO2026-10-01
00612553000194VERISHARTMANN USA, INC.FRO2026-10-01
00194346726707equateWAL-MART STORES, INC.FRO2026-09-30
00194346726714equateWAL-MART STORES, INC.FRO2026-09-30
10885380214714CurityCardinal Health 200, LLCFRO2026-09-30
10885380214738CurityCardinal Health 200, LLCFRO2026-09-30
00810226440944ViveCareVIVE HEALTH LLCFRO2026-09-29
00810226440951ViveCareVIVE HEALTH LLCFRO2026-09-29
00810226440968ViveCareVIVE HEALTH LLCFRO2026-09-29
00810226442542ViveCareVIVE HEALTH LLCFRO2026-09-29
00810226442559ViveCareVIVE HEALTH LLCFRO2026-09-29
00810226442566ViveCareVIVE HEALTH LLCFRO2026-09-29
00810178885329Vive CareVIVE HEALTH LLCFRO2026-09-28
10885380214707CurityCardinal Health 200, LLCFRO2026-09-28
10885380214721CurityCardinal Health 200, LLCFRO2026-09-28
10885380214745CurityCardinal Health 200, LLCFRO2026-09-28
10885380214752CurityCardinal Health 200, LLCFRO2026-09-28
10885380214769CurityCardinal Health 200, LLCFRO2026-09-28
10885380214776CurityCardinal Health 200, LLCFRO2026-09-28
10885380214783CurityCardinal Health 200, LLCFRO2026-09-28
10885380214790CurityCardinal Health 200, LLCFRO2026-09-28
10885380214806CurityCardinal Health 200, LLCFRO2026-09-28
10888277415010MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-09-04
10888277415027MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-09-04
00841277111187Novera RenewHarps USA, Inc.FRO2026-08-26
00841277111200Novera RenewHarps USA, Inc.FRO2026-08-26
00841277111224Novera RenewHarps USA, Inc.FRO2026-08-26
00841277111323Novera RenewHarps USA, Inc.FRO2026-08-26
00850087488723CeeportCEEPORT INC.FRO2026-08-26