FDA.report

Bandage Shears

Primary DI
00616784418315
Brand
Bandage Shears
Company
Dynarex Corporation
Model
4183
Device description
Bandage Shears 7.5" Orange
Published
2020-11-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
JOKScissors, Medical, Disposable

Product Code Classifications

CodeDeviceSpecialtyClass
JOKScissors, Medical, DisposableGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00616784418339PackageGS14In Commercial Distribution
00616784418322PrimaryGS10
00616784418315Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784418339006167844183396167844183390616784418339
00616784418322006167844183226167844183220616784418322
00616784418315006167844183156167844183150616784418315

GMDN Terms

TermDefinition
Bandage scissors, reusableA hand-held manual instrument intended to be used to cut bandages and cloth. Typically a robust instrument, it comprises two pivoted blades provided with finger and thumb holes in the handles. The distal end of the blades may be different shapes and are usually rounded for safety; one blade may extend in front of the other and have an olive tip that is placed under the bandage. It is typically made of high-grade stainless steel and some may use carbide inserts for the cutting edge. This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
008124539
Device count
50
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
false
Sterilization required before use
false

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