FDA.report

McKesson

Primary DI
00612479124356
Brand
McKesson
Company
MCKESSON MEDICAL-SURGICAL INC.
Model
13-213
Device description
Premium Elastic Bandages WITH STRETCH CLIPS 3" x 5 yds.
Published
2019-04-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
FQMBandage, Elastic

Product Code Classifications

CodeDeviceSpecialtyClass
FQMBandage, ElasticGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00612479124356PackageGS15In Commercial Distribution
00612479124233PrimaryGS10
00612479237629Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00612479124356006124791243566124791243560612479124356
00612479124233006124791242336124791242330612479124233
00612479237629006124792376296124792376290612479237629

GMDN Terms

TermDefinition
Pressure bandage, non-latex, non-sterile, single-useA non-sterile strip or roll of fabric or plastic material (non-latex) intended to be applied to and compress a local area of the body for one or more preventative/therapeutic applications (e.g., prevent oedema, support injuries associated with minor trauma, treat disorders of venous return). It may be described as a sports tape intended for support while allowing movement, or described as a compression bandage; it is not intended to be used in association with open wounds. It is normally available [non-prescription] over-the-counter (OTC) for use in the home or healthcare facility. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
023904428
Device count
10
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
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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00612479278387McKesson16-61682026-01-26
00612479278431McKesson16-618102026-01-26

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