FDA.report

AVID TruCustom

Primary DI
20809160154783
Brand
AVID TruCustom
Company
AVID MEDICAL, INC.
Model
WH0022-00_0003
Published
2017-07-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
FQLSTOCKING, MEDICAL SUPPORT (FOR GENERAL MEDICAL PURPOSES)

Product Code Classifications

CodeDeviceSpecialtyClass
FQLStocking, Medical Support (For General Medical Purposes)General Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20809160154783PackageGS150In Commercial Distribution
10809160154786PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2080916015478320809160154783
1080916015478610809160154786

GMDN Terms

TermDefinition
StockinetteA knitted, seamless, expandable tubing, typically made of cotton, that is open at both ends and intended to be used to hold bandages in place; to place uniform pressure on a leg, finger, arm, or other part of an extremity; to pad the area under a cast, splint or orthosis; or to cover a stump when a prosthesis is worn. This is a single-use device.

Sterilization Methods

Method
Ethylene Oxide

Regulatory Flags

DUNS number
015623119
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

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20809160517151HalyardVAML019-09_0004VAML019-092026-03-23
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20809160517182HalyardOSTK19-01_0007OSTK19-012026-03-23
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20809160517205HalyardVAML058_0017VAML0582026-03-23
20809160517212HalyardSAMT100-12_0007SAMT100-122026-03-23
20809160517229HalyardESED52-01_0013ESED52-012026-03-23
20809160516734HalyardLIFE0156-03_0008LIFE0156-032026-03-20
20809160516741HalyardWERP43-01_0002WERP43-012026-03-20
20809160516758HalyardWEGL20-01_0004WEGL20-012026-03-20
20809160516765HalyardWEHY18-01_0002WEHY18-012026-03-20
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