FDA.report

Elastic Bandage with Self-Closure

Primary DI
00616784366036
Brand
Elastic Bandage with Self-Closure
Company
DYNAREX CORPORATION
Model
3660
Device description
Elastic Bandage with Self-Closure, 4"x5yds
Published
2021-09-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
FQMBandage, Elastic

Product Code Classifications

CodeDeviceSpecialtyClass
FQMBandage, ElasticGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00616784366036PackageGS15In Commercial Distribution
00616784366029PrimaryGS10
00616784366012Unit of UseGS10
00810180844628Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784366036006167843660366167843660360616784366036
00616784366029006167843660296167843660290616784366029
00616784366012006167843660126167843660120616784366012
00810180844628008101808446288101808446280810180844628

GMDN Terms

TermDefinition
Dressing-supportive tube/strip, single-useAn elastic device intended to be worn over/around a limb (arm/leg) and/or finger to cover and support a dressing on a wound/injury (e.g., burn, postoperative, skin condition). It may be referred to as a dressing/bandage retainer and is either in the form of a generic tube (i.e., not a specific garment such as a sock, glove, vest, shorts, or hat) or gripping elastic strip made of synthetic material (e.g., nylon/elastane), and is available in various sizes for daily use in the home or healthcare facility. It may additionally be intended for use at other anatomical sites (where size is appropriate) however it is not dedicated to the abdomen/thorax. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
008124539
Device count
10
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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