FDA.report

Dukal

Primary DI
20665973016249
Brand
Dukal
Company
Dukal LLC
Model
385L
Catalog number
385L
Device description
Scrub Shirt, SMS, Large, Dark Blue
Published
2022-12-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
LYUACCESSORY, SURGICAL APPAREL

Product Code Classifications

CodeDeviceSpecialtyClass
LYUAccessory, Surgical ApparelGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20665973016249PackageGS15In Commercial Distribution
10665973016242PrimaryGS10
30665973016246Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2066597301624920665973016249
1066597301624210665973016242
3066597301624630665973016246

GMDN Terms

TermDefinition
Scrub suit, single-useA two-piece garment designed to be worn by healthcare staff to facilitate hygienic conditions typically in areas where surgery is performed. It typically consists of a shirt and pants composed of disposable materials and is intended to provide a barrier to help prevent cross-contamination of infectious agents between staff and patients. This is a single-use garment.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(631)656-3800kmckigney@dukal.com

Regulatory Flags

DUNS number
791014871
Device count
10
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 DIBrandModelCatalogPublished
20665973032638Dukal550055002026-01-12
20665973032645Dukal550155012026-01-12
30665973032659Dukal550255022026-01-12
30665973032666Dukal550355032026-01-12
20665973033024Dukal553055302026-02-26
20665973020918Dukal11130111302026-01-30
20665973020932Dukal11127111272026-01-30
30665973032611Dukal986098602025-10-31
30665973032628Dukal986198612025-10-31
30665973032598DukalK-10040K-100402025-09-18
30665973032451UnipackUPP-1015UPP-10152025-06-01
30665973032475UnipackUPP-223UPP-2232025-06-01
30665973032482UnipackUPP-225UPP-2252025-06-01
30665973032499UnipackUPP-29UPP-292025-06-01
30665973032505UnipackUPP-3212UPP-32122025-06-01
30665973032512UnipackUPP-3565UPP-35652025-06-01
30665973032529UnipackUPP-4212UPP-42122025-06-01
30665973032536UnipackUPP-5211UPP-52112025-06-01
30665973032543UnipackUPP-5275UPP-52752025-06-01
30665973032550UnipackUPP-7513UPP-75132025-06-01

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Primary DIBrandCompanyProduct codePublished
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00810219420113American Hospital SupplyAmerican Hospital Supply LLCLYU2026-03-10
08057147052111MDU7023S UNIVET SRLLYU2026-03-02
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