Scleral buckling device, non-bioabsorbable - A sterile, non-bioabsorbable device intended to - FCI S A S FCI 20 22

Duns Number:763408366

Device Description: A sterile, non-bioabsorbable device intended to be implanted for intrascleral and episcler A sterile, non-bioabsorbable device intended to be implanted for intrascleral and episcleral buckling for the surgical treatment of retinal detachment. It is typically a moulded solid silicone or silicone sponge device available in a variety of shapes and sizes that is used to compress the retina long-term (up to months) to support its reattachment following the operative treatment of severe retinal detachment. This device, also known as a scleral buckling component, will occupy the intraocular space to provide compression against the retina so that it can reattach. It is typically removed after a period of time depending upon the clinical findings.

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More Product Details

Catalog Number

S5.1205U

Brand Name

Scleral buckling device, non-bioabsorbable

Version/Model Number

STRIP (7.2 mm) TYPE 31

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

HQX

Product Code Name

Implant, Orbital, Extra-Ocular

Device Record Status

Public Device Record Key

2deda361-9ec4-4816-922d-45f587f809df

Public Version Date

December 22, 2021

Public Version Number

2

DI Record Publish Date

March 06, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"FCI S A S FCI 20 22" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 82
2 A medical device with a moderate to high risk that requires special controls. 291
U Unclassified 60