FDA.reportPublic FDA data

FLEXICON ST 4X4.1 96/CS

Primary DI
20612553013228
Brand
FLEXICON ST 4X4.1 96/CS
Company
PAUL HARTMANN AG
Model
19400000
Device description
FLEXICON ST 4X4.1 96/CS
Published
2020-09-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FQMBandage, Elastic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FQMBandage, ElasticGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20612553013228PackageGS196In Commercial Distribution
40612553013222PackageGS18In Commercial Distribution
10612553013221PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2061255301322820612553013228
4061255301322240612553013222
1061255301322110612553013221

GMDN Terms#

Term, Definition table
TermDefinition
Woven gauze roll, sterileA sterile device in the form of a long strip of stretchable, absorbent, woven material (e.g., cotton, cellulose), wound into a roll, and typically designed for a variety of applications (non-dedicated) such as a primary wound dressing, dressing retention, injury padding and compression. It is not a dedicated pressure dressing and does not include latex. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
315768788
Device count
1
DM exempt
false
Premarket exempt
true
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04049500834919HydroTac transparent 5cmx7,5cm st P10685900 HydroTac transparent 5cmx7,5cm st P106859002020-09-01
04049500834940HydroTac transparent 10cmx10cm st P10685901 HydroTac transparent 10cmx10cm st P106859012020-09-01
04049500834971HydroTac transparent 10x20cm st P10 C6685902 HydroTac transparent 10x20cm st P10 C66859022020-09-01
04049500835008HydroTac transparent 20x20cm st P10685903 HydroTac transparent 20x20cm st P106859032020-09-01
04049500835039HydroTac transparent comf. 8x8cm st P10685920 HydroTac transparent comf. 8x8cm st P106859202020-09-01
04049500835091HydroTac transp. comf. 10x20cm st P10685922 HydroTac transp. comf. 10x20cm st P106859222020-09-01
04049500835121HydroTac transp. comf. 6,5x10cm st P10685923 HydroTac transp. comf. 6,5x10cm st P106859232020-09-01
04052199273501HydroTac transparent 5x7,5cm steril P10685905 HydroTac transparent 5x7,5cm steril P102020-09-01
04052199273563HydroTac transp. comfort 8x8cm st P10685925 HydroTac transp. comfort 8x8cm st P102020-09-01
04052199273600HydroTac transp. comf.12,5x12,5cm st P10685926 HydroTac transp. comf.12,5x12,5cm st P102020-09-01
04052199273648HydroTac transp. comf. 10x20cm st P10685927 HydroTac transp. comf. 10x20cm st P102020-09-01
04052199273686HydroTac transp. comf. 6,5x10cm st P10685928 HydroTac transp. comf. 6,5x10cm st P102020-09-01
04052199274201HydroTac transparent 10x10cm steril P10685906 HydroTac transparent 10x10cm steril P102020-09-01
04052199274249HydroTac transparent 10x20cm steril P10685907 HydroTac transparent 10x20cm steril P102020-09-01
04052199274287HydroTac transparent 20x20cm steril P10685908 HydroTac transparent 20x20cm steril P102020-09-01
04049500835060HydroTac transp.comf. 12,5x12,5cm st P10685921 HydroTac transp.comf. 12,5x12,5cm st P106859212020-09-01
04052199807188Zetuvit Plus413926 Zetuvit Plus Shapes Oval4139262026-09-28
04052199810157Foliodrape Protect Plus936022 Foliodrape Protect Plus One Drape Solution 9360222026-03-09
04052199810171Foliodrape Protect Plus936023 Foliodrape Protect Plus One Drape Solution 9360232026-03-09
04052199810195Foliodrape Protect Plus936024 One Drape Solution Knee drape with 1 stocki9360242026-03-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06975675785054RESCUE RESSENTIALSEMSRUN GROUPFQM2026-10-27
20885380214377KendallCardinal Health 200, LLCFQM2026-10-12
20885380214384KendallCardinal Health 200, LLCFQM2026-10-12
20885380214391KendallCardinal Health 200, LLCFQM2026-10-12
20885380214407KendallCardinal Health 200, LLCFQM2026-10-12
20885380214414KendallCardinal Health 200, LLCFQM2026-10-12
07333350030384Tubigrip®Mölnlycke Health Care ABFQM2026-09-21
07333350102111Tubigrip®Mölnlycke Health Care ABFQM2026-09-21
07333350354831Tubigrip®Mölnlycke Health Care ABFQM2026-09-21
07333350472917Tubigrip®Mölnlycke Health Care ABFQM2026-09-21
07333350589110Tubigrip®Mölnlycke Health Care ABFQM2026-09-21
07333350644635Tubigrip®Mölnlycke Health Care ABFQM2026-09-21
07333350721589Tubigrip®Mölnlycke Health Care ABFQM2026-09-21
07333350753856Tubigrip®Mölnlycke Health Care ABFQM2026-09-21
07333350758288Tubigrip®Mölnlycke Health Care ABFQM2026-09-21
07333350929640Tubigrip®Mölnlycke Health Care ABFQM2026-09-21
07333350094850Tubigrip®Mölnlycke Health Care ABFQM2026-09-18
07333350874889Tubigrip®Mölnlycke Health Care ABFQM2026-09-18
00850087488808CeeportCEEPORT INC.FQM2026-08-26
00850087488815CeeportCEEPORT INC.FQM2026-08-26
00850087488822CeeportCEEPORT INC.FQM2026-08-26
00850087488839CeeportCEEPORT INC.FQM2026-08-26
00050428124505CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFQM2026-08-14
00850088144024CARBOUNingbo kehu Medical Technology Co.,Ltd.FQM2026-07-14
00850088144031CARBOUNingbo kehu Medical Technology Co.,Ltd.FQM2026-07-14
00850088144048CARBOUNingbo kehu Medical Technology Co.,Ltd.FQM2026-07-14
00850088144055CARBOUNingbo kehu Medical Technology Co.,Ltd.FQM2026-07-14
00850088144062CARBOUNingbo kehu Medical Technology Co.,Ltd.FQM2026-07-14
00850088144079CARBOUNingbo kehu Medical Technology Co.,Ltd.FQM2026-07-14
00850088144086CARBOUNingbo kehu Medical Technology Co.,Ltd.FQM2026-07-14