FDA.reportPublic FDA data

MediChoice

Primary DI
10885632102790
Brand
MediChoice
Company
OWENS & MINOR DISTRIBUTION, INC.
Model
SJ0604
Device description
Jacket Staff Knit Collar Cuff Snap Front Fluid-Resistant Large Spunbond Meltblown Spunbond Blue Disposable Not Made With Natural Rubber Latex MediChoice
Published
2020-09-22
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
50885632102798PrimaryGS10
10885632102790Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088563210279850885632102798
1088563210279010885632102790

GMDN Terms#

Term, Definition table
TermDefinition
Professional examination gown, single-useA garment made of natural and/or synthetic materials intended to be worn by healthcare providers, sometimes over scrub suits, while examining patients. It can be fluid resistant or impervious to fluid. An examination gown is used during patient examination procedures to protect both the patient and staff from the transfer of contaminants such as microorganisms or body fluids. This is a single-use garment.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
007941230
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
10885632434266Halyard563482026-05-22
10885632434303Halyard563522026-05-22
10885632468490Halyard614862026-05-22
10885632468506Halyard614872026-05-22
10885632468513Halyard614882026-05-22
10885632468520Halyard614892026-05-22
10885632509032Halyard620732026-05-22
10885632509049Halyard620742026-05-22
10885632509056Halyard620752026-05-22
10885632509063Halyard620762026-05-22
10885632510199Halyard620772026-05-22
10885632521751SurgiTrackSM450130D17D2026-05-22
10885632517105SurgiTrackSM4500410F102026-03-23
10885632516429SurgiTrackSM4500309F242026-03-17
30885632495469HalyardIDSG10012026-03-13
20885632495851HalyardIDSG10022026-03-13
20885632495868HalyardIDSG10032026-03-13
20885632495875HalyardIDSG10042026-03-13
20885632495882HalyardIDSG10052026-03-13
20885632496742HalyardIDSG10062026-03-13

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