FDA.reportPublic FDA data

McKesson

Primary DI
00612479106161
Brand
McKesson
Company
MCKESSON MEDICAL-SURGICAL INC.
Model
16-1101
Device description
Exam Shorts NON-WOVEN | BLUE MEDIUM (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
00612479106161PackageGS14In Commercial Distribution
00612479205352PrimaryGS10
00612479236486Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00612479106161006124791061616124791061610612479106161
00612479205352006124792053526124792053520612479205352
00612479236486006124792364866124792364860612479236486

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810219420120American Hospital SupplyAmerican Hospital Supply LLCLYU2026-03-11
00810219420090American Hospital SupplyAmerican Hospital Supply LLCLYU2026-03-10
00810219420113American Hospital SupplyAmerican Hospital Supply LLCLYU2026-03-10
08057147052111MDU7023S UNIVET SRLLYU2026-03-02
G1493806305TBS DentalACME ENTERPRISE.LYU2026-03-02
G149TBSMH107TBS DentalACME ENTERPRISE.LYU2026-03-02
10810132043731HCSConcordance Healthcare Solutions LLCLYU2026-01-16
20810141933488VIVIT SupplyVivit Supply LLCLYU2025-09-18
20810141933495VIVIT SupplyVivit Supply LLCLYU2025-09-18
20810141933501VIVIT SupplyVivit Supply LLCLYU2025-09-18
20810141933518VIVIT SupplyVivit Supply LLCLYU2025-09-18
20810141933525VIVIT SupplyVivit Supply LLCLYU2025-09-18
20810141933532VIVIT SupplyVivit Supply LLCLYU2025-09-18
20810141933549VIVIT SupplyVivit Supply LLCLYU2025-09-18
20810141933556VIVIT SupplyVivit Supply LLCLYU2025-09-18
20810141933563VIVIT SupplyVivit Supply LLCLYU2025-09-18
20810141933570VIVIT SupplyVivit Supply LLCLYU2025-09-18
20810141933587VIVIT SupplyVivit Supply LLCLYU2025-09-18
20810141933594VIVIT SupplyVivit Supply LLCLYU2025-09-18
20810141933600VIVIT SupplyVivit Supply LLCLYU2025-09-18
20810141933617VIVIT SupplyVivit Supply LLCLYU2025-09-18
20810141933624VIVIT SupplyVivit Supply LLCLYU2025-09-18
20810141933631VIVIT SupplyVivit Supply LLCLYU2025-09-18
20810141933648VIVIT SupplyVivit Supply LLCLYU2025-09-18
20810141933655VIVIT SupplyVivit Supply LLCLYU2025-09-18
20810141933662VIVIT SupplyVivit Supply LLCLYU2025-09-18
20810141933679VIVIT SupplyVivit Supply LLCLYU2025-09-18
20810141933686VIVIT SupplyVivit Supply LLCLYU2025-09-18
20810141933693VIVIT SupplyVivit Supply LLCLYU2025-09-18
20810141933709VIVIT SupplyVivit Supply LLCLYU2025-09-18