FDA.report

Degania

Primary DI
47290001603268
Brand
Degania
Company
DEGANIA SILICONE LTD
Model
231241280DS
Device description
Identi Loops super maxi white 18" sterile
Published
2019-01-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
DXCClamp, Vascular

Product Code Classifications

CodeDeviceSpecialtyClass
DXCClamp, VascularCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
27290001603264PackageGS110In Commercial Distribution
47290001603268PackageGS110In Commercial Distribution
07290001603260PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
2729000160326427290001603264
4729000160326847290001603268
07290001603260072900016032607290001603260

GMDN Terms

TermDefinition
Surgical vessel loopA nonimplantable cord intended to be used during a surgical procedure to assist a surgeon to identify, retract and occlude blood vessels, tendons and nerves. It is constructed of synthetic polymer and is typically coloured to facilitate visualization. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
600007082
Device count
1
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
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

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07290000846934AQUARIUS 103073001280AQ 2016-11-01
27290001608962Aquarius1032831080AQ2023-01-31
27290001608986Aquarius1032861080AQ2023-01-31

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