FDA.reportPublic FDA data

MAXI-GARD

Primary DI
00304040139837
Brand
MAXI-GARD
Company
HENRY SCHEIN, INC.
Model
5702309
Catalog number
5702309
Device description
Maxi-Gard Lab Coat Black
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

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
10304040139834PrimaryGS10
00304040139837Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1030404013983410304040139834
00304040139837003040401398373040401398370304040139837

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.

Sterilization Methods#

Method table
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

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

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