FDA.report

Unipack

Primary DI
40665973030331
Brand
Unipack
Company
UNIPACK MEDICAL CORPORATION
Model
UGJ-6509-XXL
Catalog number
UGJ-6509-XXL
Device description
FitMe Lab Jackets XX-Large Raspberry Pink
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
40665973030331PackageGS15In Commercial Distribution
10665973030330PrimaryGS10
00665973030333Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
4066597303033140665973030331
1066597303033010665973030330
00665973030333006659730303336659730303330665973030333

GMDN Terms

TermDefinition
Isolation gown, single-useA garment made of natural and/or synthetic materials intended to be worn by healthcare providers or visitors to isolate themselves from patients. The isolation gown helps to protect the patient (e.g., burn patients) from the transfer of infectious agents carried by the healthcare provider or visitor; or it may help to protect the healthcare provider or visitor from a contagious agent which has infected the patient. This is a single-use garment.

Sterilization Methods

Method

Contacts

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

Regulatory Flags

DUNS number
018319397
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
10850008682237UnipackUMA-9121-FUMA-9121-F2022-12-07
10850008682244UnipackUMA-9122-RUMA-9122-R2022-12-07
10850008682251UnipackUMA-9123-AUMA-9123-A2022-12-07
D784UBC8010E5UnipackUBC-8010EUBC-8010E2022-12-07
D784UBC8011A5UnipackUBC-8011AUBC-8011A2022-12-07
D784UBC8012B5UnipackUBC-8012BUBC-8012B2022-12-07
D784UBC8013F5UnipackUBC-8013FUBC-8013F2022-12-07
D784UBC80235UnipackUBC-8023UBC-80232022-12-07
D784UBC80245UnipackUBC-8024UBC-80242022-12-07
D784UBC80255UnipackUBC-8025UBC-80252022-12-07
10850008682213UnipackUAT-9051UAT-90512022-12-06
10850008682220UnipackUAT-9052UAT-90522022-12-06
10850008682367UnipackUAT-9053UAT-90532022-12-06
40665973029175UnipackUBC-6311UBC-63112022-12-06
40665973029182UnipackUBC-6312UBC-63122022-12-06
40665973029199UnipackUBC-6401UBC-64012022-12-06
40665973029205UnipackUBC-6402UBC-64022022-12-06
40665973029212UnipackUBC-6403UBC-64032022-12-06
40665973029229UnipackUBC-6404UBC-64042022-12-06
40665973029236UnipackUBC-6405UBC-64052022-12-06

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