FDA.reportPublic FDA data

Krinkle Gauze Roll, Non-Sterile

Primary DI
00616784316239
Brand
Krinkle Gauze Roll, Non-Sterile
Company
Dynarex Corporation
Model
3162
Device description
"Krinkle Gauze Roll, Non-Sterile 4.5""x4.1yd, 6-ply"
Published
2021-06-21
Public version status
Update
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
00616784316239PrimaryGS10
00810180844086Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784316239006167843162396167843162390616784316239
00810180844086008101808440868101808440860810180844086

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
100
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Contains natural rubber latex
true

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00840117305656Resp-O2 Heat Moisture Exchanger + B/V Filter (HMEF) 1500301002021-04-22
00840117305847Resp-O2 Heat Moisture Exchanger + Filter (HMEF) 1500301022021-04-22
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00840117307766Ever-Soft Positioning Wedge130032021-04-22
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00616784304113Dmecare Solutions Solid Seat Insert13041-162021-09-01
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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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