FDA.reportPublic FDA data

SORBALGON 2X2 10/BX

Primary DI
10612553013641
Brand
SORBALGON 2X2 10/BX
Company
HARTMANN USA, INC.
Model
49200000
Device description
SORBALGON 2X2 10/BX
Published
2020-09-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
NADDressing, Wound, Occlusive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NADDressing, Wound, OcclusiveGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04049500213110PackageGS120Not in Commercial Distribution
20612553013648PackageGS110Not in Commercial Distribution
10612553013641PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049500213110040495002131104049500213110
2061255301364820612553013648
1061255301364110612553013641

Regulatory Flags#

DUNS number
010137511
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

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
00612553000187VERIS906012 2X2 sheet 15/BX9060122026-10-01
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

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