FDA.reportPublic FDA data

MediChoice

Primary DI
20885632070713
Brand
MediChoice
Company
OWENS & MINOR DISTRIBUTION, INC.
Model
GZBN4003
Device description
"Gauze Bandage Roll Bulk Non-Sterile 4.5"" x 4.1 yd Large 100% Cotton White 6-Ply Single Use Only Not Made With Natural Rubber Latex"
Published
2020-09-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
NABGauze / sponge,nonresorbable for external use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NABGauze / Sponge,Nonresorbable For External UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20885632070713PrimaryGS10
10885632070716Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088563207071320885632070713
1088563207071610885632070716

GMDN Terms#

Term, Definition table
TermDefinition
Woven gauze roll, non-sterileA non-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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity0 Percent (%) Relative Humidity75 Percent (%) Relative Humidity

Regulatory Flags#

DUNS number
007941230
Device count
100
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10885632434266Halyard563482026-05-22
10885632434303Halyard563522026-05-22
10885632468490Halyard614862026-05-22
10885632468506Halyard614872026-05-22
10885632468513Halyard614882026-05-22
10885632468520Halyard614892026-05-22
10885632509032Halyard620732026-05-22
10885632509049Halyard620742026-05-22
10885632509056Halyard620752026-05-22
10885632509063Halyard620762026-05-22
10885632510199Halyard620772026-05-22
10885632521751SurgiTrackSM450130D17D2026-05-22
10885632521607SurgiTrackSM4500452F842026-05-19
10885632521638SurgiTrackSM45007841332026-05-19
10885632521522SurgiTrackSM4500410A672026-05-18
10885632521577SurgiTrackSM450041BC2C2026-05-18
10885632521584SurgiTrackSM45004117402026-05-18
10885632521591SurgiTrackSM45004113802026-05-18
10885632521317SurgiTrackSM450178CA972026-05-13
10885632434228Halyard563442026-05-12

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