FDA.report

Unipack

Primary DI
D784UBC80365
Brand
Unipack
Company
UNIPACK MEDICAL CORPORATION
Model
UBC-8036
Catalog number
UBC-8036
Device description
Handpiece Sleeves High Speed Universal 1" x 9"
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
NRDUnit, operative dental, accessories

Product Code Classifications

CodeDeviceSpecialtyClass
NRDUnit, Operative Dental, AccessoriesDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D784UBC80365PackageHIBCC36In Commercial Distribution
D784UBC80361PrimaryHIBCC0
D784UBC80360Unit of UseHIBCC0

GMDN Terms

TermDefinition
Medical equipment drape, single-useA flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or equipment components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the contents from soiling and contamination when used in the vicinity of, or entered into, a hygienic area. It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device.

Sterilization Methods

Method

Contacts

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

Regulatory Flags

DUNS number
018319397
Device count
500
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
false
Sterilization required before use
false

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D784UBC8013F5UnipackUBC-8013FUBC-8013F2022-12-07
D784UBC80235UnipackUBC-8023UBC-80232022-12-07
D784UBC80245UnipackUBC-8024UBC-80242022-12-07
D784UBC80255UnipackUBC-8025UBC-80252022-12-07

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