FDA.reportPublic FDA data

McKesson

Primary DI
00612479106185
Brand
McKesson
Company
MCKESSON MEDICAL-SURGICAL INC.
Model
16-1103
Device description
Exam Shorts NON-WOVEN | BLUE x-Large (25/bg, 4/cs)
Published
2021-08-26
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

Product Codes#

Code, Name table
CodeName
LYUAccessory, Surgical Apparel

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LYUAccessory, Surgical ApparelGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00612479106185PackageGS14In Commercial Distribution
00612479205376PrimaryGS10
00612479236509Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00612479106185006124791061856124791061850612479106185
00612479205376006124792053766124792053760612479205376
00612479236509006124792365096124792365090612479236509

GMDN Terms#

Term, Definition table
TermDefinition
Surgical patient underpantsA pair of underpants/shorts made of natural and/or synthetic materials (e.g., paper, cloth, plastic) intended to be worn by a patient for comfort, covering, and a degree of warmth before, during, and/or after a surgical intervention; it may have an opening(s) to allow access to body orifices. It is not specifically intended for support, and is typically loose fitting to accommodate a variety of sizes; it does not include antimicrobial properties. This is a single-use garment.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
023904428
Device count
25
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20612479282852McKessonM-1669H2026-05-26
20612479282883McKessonM-662G2026-05-26
20612479282890McKessonM-1667G2026-05-26
20612479282906McKessonM-1667H2026-05-26
20612479282913McKessonM-698G2026-05-26
20612479282920McKessonM-1666G2026-05-26
20612479282937McKessonM-1698G2026-05-26
20612479282944McKessonM-663G2026-05-26
20612479283019McKessonM-699G2026-05-26
20612479283194McKessonM-8699G2026-05-26
20612479283200McKessonM-8682G2026-05-26
20612479283217McKessonM-8698G2026-05-26
20612479283224McKessonM-8686G2026-05-26
20612479283231McKessonM-8697G2026-05-26
20612479283248McKessonM-8695G2026-05-26
20612479283255McKessonM-685G2026-05-26
20612479283385McKessonM-J494G2026-05-26
20612479283392McKessonM-J496G2026-05-26
20612479283408McKessonM-J493G2026-05-26
20612479283415McKessonM-J546G2026-05-26

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