FDA.reportPublic FDA data

MAXI-GARD

Primary DI
10304040139759
Brand
MAXI-GARD
Company
HENRY SCHEIN, INC.
Model
5702305
Catalog number
5702305
Device description
Maxi-Gard Jacket Teal
Published
2021-05-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
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
10304040139759PrimaryGS10
00304040139752Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1030404013975910304040139759
00304040139752003040401397523040401397520304040139752

GMDN Terms#

Term, Definition table
TermDefinition
Assistive jacketAn assistive garment that is specially designed/adapted for use by a person with a disability to be worn on the upper torso and shaped with full-length sleeves, a collar, and an opening at the front. It may be worn by a male or a female and will typically be constructed with features that accommodate the disability, e.g., large buttons, Velcro fasteners, zip fasteners, wide sleeves and large pockets. Coats and jackets for outdoor use are not included in this GMDN code.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a cool dry place, avoid sunlight.

Regulatory Flags#

DUNS number
012430880
Device count
10
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10304040196974Henry Schein570586457058642026-05-14
10304040196981Henry Schein570586557058652026-05-14
10304040196998Henry Schein570586657058662026-05-14
10304040197001Henry Schein570586757058672026-05-14
10304040197018Henry Schein570586857058682026-05-14
10304040059446Henry Schein900445490044542019-02-13
10304040196790Henry Schein570584657058462026-04-21
10304040196806Henry Schein570584957058492026-04-21
10304040196660Henry Schein570583757058372026-04-17
10304040196677Henry Schein570583857058382026-04-17
10304040196684Henry Schein570583957058392026-04-17
10304040196691Henry Schein570584057058402026-04-17
10304040196707Henry Schein570584157058412026-04-17
10304040196714Henry Schein570584257058422026-04-17
10304040196653Henry Schein570583157058312026-04-10
00304040000236Henry Schein100-7773100-77732015-09-25
10304040119034Henry Schein570163357016332020-02-05
10304040119058Henry Schein570163457016342020-02-05
10304040119065Henry Schein570163657016362020-02-05
10304040119089Henry Schein570163857016382020-02-05

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