FDA.report

Unipack Sterilization Wrap

Primary DI
D784UPP15151
Brand
Unipack Sterilization Wrap
Company
UNIPACK MEDICAL CORPORATION
Model
UPP-1515
Catalog number
UPP-1515
Device description
15" x 15" - Sterilization Wrap for Steam / ETO / Gamma
Published
2019-12-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories

Product Code Classifications

CodeDeviceSpecialtyClass
KCTSterilization Wrap Containers, Trays, Cassettes & Other AccessoriesGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D784UPP15151PrimaryHIBCC0
D784UPP15150Unit of UseHIBCC0

GMDN Terms

TermDefinition
Sterilization packaging, single-useA device, typically in the form of a paper sheet, envelope, bag, wrap, or similar, intended to be used to contain medical devices that are to be sterilized. It is designed to allow sterilization of the enclosed medical device and also to maintain sterility of the device until the packaging is opened for use of the device, or until a predetermined shelf date is expired. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
866-686-47224info@unipackmedical.com
+1(866)686-47224info@unipackmedical.com

Regulatory Flags

DUNS number
018319397
Device count
100
DM exempt
false
Premarket exempt
false
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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