FDA.report

Stretch Gauze Bandage Roll, Sterile

Primary DI
00616784311623
Brand
Stretch Gauze Bandage Roll, Sterile
Company
DYNAREX CORPORATION
Model
3116
Device description
Stretch Gauze Bandage Roll, Sterile, 6"x4.1yd
Published
2021-06-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
FQMBandage, Elastic

Product Code Classifications

CodeDeviceSpecialtyClass
FQMBandage, ElasticGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00616784311623PackageGS16In Commercial Distribution
00616784311630PackageGS18In Commercial Distribution
00616784311616PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784311623006167843116236167843116230616784311623
00616784311630006167843116306167843116300616784311630
00616784311616006167843116166167843116160616784311616

GMDN Terms

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

Regulatory Flags

DUNS number
008124539
Device count
1
DM exempt
false
Premarket exempt
true
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

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