FDA.report

MAXI-GARD

Primary DI
00304040139752
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
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
LYUACCESSORY, SURGICAL APPAREL

Product Code Classifications

CodeDeviceSpecialtyClass
LYUAccessory, Surgical ApparelGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10304040139759PrimaryGS10
00304040139752Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1030404013975910304040139759
00304040139752003040401397523040401397520304040139752

GMDN Terms

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

TypeLowHighCondition
Special Storage Condition, Specify00Store in a cool dry place, avoid sunlight.

Sterilization Methods

Method

Regulatory Flags

DUNS number
012430880
Device count
10
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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00304040187647Zirlux920006392000632026-02-04
00304040187654Zirlux920006492000642026-02-04
00304040187661Zirlux920006592000652026-02-04

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