FDA.reportPublic FDA data

Epiphany

Primary DI
B28101812010
Brand
Epiphany
Company
PANTHEON SPINAL, LLC
Model
1
Catalog number
1018-1201
Device description
Fraizer Suction Tube 12 FR
Published
2018-05-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAXIntervertebral Fusion Device With Bone Graft, LumbarOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K113781000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K113781000PANTHEON SPINAL IBFD SYSTEMPantheon Spinal2013-04-26MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B28101812010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical/emergency suction cannula, non-illuminating, single-useAn atraumatic, invasive, hand-operated, single-lumen, rigid/semi-rigid tube designed as a conduit for aspiration of body cavities, wounds, or surgical sites to facilitate observation and/or to clear an airway obstruction. It is not dedicated to dental, intrauterine, or liposuction procedures, and is neither an ophthalmic nor an intravascular device; it is not designed for surgical irrigation. Sometimes referred to as a suction tube or tip, it may incorporate a handle with side valve(s)/hole(s), and may be provided with a stylet, sheath, and/or connection tubing; it does not include a light source or fibreoptic bundle. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
5122154888info@pantheon-spinal.com

Regulatory Flags#

DUNS number
071012634
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B528100800001003020EPIPHANY11008-0000 1003-022018-01-21
B528100900001003030EPIPHANY11009-0000 1003-032018-01-21
B528101000000EPIPHANY11010-00002018-01-21
B528101100000EPIPHANY11011-00002018-01-21
B528101200000EPIPHANY11012-00002018-01-21
B528PSM11W0Orion Sacroiliac Joint Fusion System1PS-M11W2020-10-12
B528PSM13W0Orion Sacroiliac Joint Fusion System1PS-M13W2020-10-12
B528100213010Yellowstone11002-13012018-05-26
B528100213020Epiphany11002-13022018-05-26
B528100310011022110Epiphany11003-1001 1022-112018-05-26
B528100310021022120Epiphany11003-1002 1022-122018-05-26
B528100418011023010EPIPHANY11004-1801 1023-012018-01-21
B528100418021023020EPIPHANY11004-1802 1023-022018-01-21
B528100418041023040EPIPHANY11004-1804 1023-042018-01-21
B528XL12184080Yellowstone1XL121840-82021-10-07
B528XL12184580Yellowstone1XL121845-82021-10-07
B528XL12185080Yellowstone1XL121850-82021-10-07
B528XL12185580Yellowstone1XL121855-82021-10-07
B528XL12186080Yellowstone1XL121860-82021-10-07
B528XL12186580Yellowstone1XL121865-82021-10-07

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Primary DI, Brand, Company table
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