FDA.reportPublic FDA data

Stretch Gauze Bandage Roll, Sterile

Primary DI
00616784311319
Brand
Stretch Gauze Bandage Roll, Sterile
Company
Dynarex Corporation
Model
3113
Device description
"Stretch Gauze Bandage Roll, Sterile, 3""x4.1yd"
Published
2021-06-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
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
00616784311326PackageGS112In Commercial Distribution
00616784311333PackageGS18In Commercial Distribution
00616784311319PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784311326006167843113266167843113260616784311326
00616784311333006167843113336167843113330616784311333
00616784311319006167843113196167843113190616784311319

GMDN Terms#

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

Regulatory Flags#

DUNS number
008124539
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
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00840117305298Resp-O2 Heat Moisture Exchanger + B/V Filter (HMEF) 1000301032021-04-22
00840117305656Resp-O2 Heat Moisture Exchanger + B/V Filter (HMEF) 1500301002021-04-22
00840117305847Resp-O2 Heat Moisture Exchanger + Filter (HMEF) 1500301022021-04-22
00840117307728Ever-Soft Positioning Wedge130012021-04-22
00840117307742Ever-Soft Positioning Wedge130022021-04-22
00840117307766Ever-Soft Positioning Wedge130032021-04-22
00840117321045Bari+Max Bariatric Gel Foam Wheelchair Cushion 24"x18"x3"130542021-04-22
00840117321052Bari+Max Bariatric Gel Foam Wheelchair Cushion 26"x20" "x3"130552021-04-22
00840117321090Bari+Max Bariatric Gel/Foam Cushion 22"x18"x3"130502021-04-22
00840117321106Bari+Max Bariatric Gel/Foam Cushion 24"x18"x3"130512021-04-22
00616784304113Dmecare Solutions Solid Seat Insert13041-162021-09-01
00616784304212DMECare Solutions Solid Seat Insert13041-182021-09-01
00616784304311DMECare Solutions Solid Seat Insert13041-202021-09-01
00616784304410DMECare Solutions Solid Seat Insert13041-222021-09-01
00616784304519DMECare Solutions Solid Seat Insert13041-242021-09-01
00840117321021Bariatric Reclining Wheelchair 24" with Elevating Leg Rest15015-24DELR2024-05-08
00840117321168DynaRide Pediatric Wheelchair with Footrest 12"15009-12DFR2024-05-09
00840117321175DynaRide Pediatric Wheelchair with Footrest 14"15009-14DFR2024-05-09
00840117322684Bariatric Reclining Wheelchair 26" with Elevating Leg Rest15015-26DELR2024-05-08

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