coflex-F™ Sterilization tray

Primary DI
04260148890321
Brand
coflex-F™ Sterilization tray
Company
Paradigm Spine GmbH
Model
RAC00000
Published
2017-06-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
KWPAppliance, Fixation, Spinal Interlaminal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K093438000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K093438000PARADIGM INTERSPINOUS FUSION PLATEParadigm Spine, LLC2010-10-06KWP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260148890321PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260148890321042601488903214260148890321

GMDN Terms#

Term, Definition table
TermDefinition
Sterilization containerA receptacle designed to hold wrapped and/or unwrapped surgical instruments (e.g. hand-held tools, surgical powered drills, hoses) during sterilization and for their subsequent storage. The container is permeable in order to allow moisture to escape from within after the sterilization process is finished, whilst protecting the contents from being contaminated. It may have features such as an expiry date label, sterile breathing filter, and stacking capabilities. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
537619731
Device count
1
Lot or batch
true
Sterilization required before use
true

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