FDA.reportPublic FDA data

SUPRAFOIL

Primary DI
00816848023916
Brand
SUPRAFOIL
Company
S JACKSON INC
Model
Code F-SS-08
Catalog number
Code F-SS-08
Device description
SupraFOIL Nylon Foil Implant, 4x4cm, 0.8mm thickness
Published
2017-09-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FTMMesh, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FTMMesh, SurgicalGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K973379000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K973379000STERILE SUPRAFOIL SMOOTH NYLON FOIL SHEETSS. Jackson, Inc.1997-09-25FTM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10816848023913PackageGS16In Commercial Distribution
00816848023916PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081684802391310816848023913
00816848023916008168480239168168480239160816848023916

GMDN Terms#

Term, Definition table
TermDefinition
Orbital wall/rim prosthesisAn implantable ocular device used to reconstruct the orbital roof, floor, medial and/or lateral walls, and/or rim of the eye socket. It may be constructed of one of a variety of materials, or a combination, including stainless steel, titanium (Ti), titanium alloy, or flexible mesh alloplastics. It is an aspherical orbital volume replacement prosthesis that will typically have a spongy outer surface (e.g., reinforced with surgical mesh) designed to encourage tissue attachment and is intended to be used in conjunction with an artificial eye (not included).

Contacts#

Phone, Email table
PhoneEmail
8003685225sales@supramid.com

Regulatory Flags#

DUNS number
069277028
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816848022964SUPRAMIDCode MPL-F20Code MPL-F202026-08-21
00816848022988SUPRAMIDCode MPL-F30Code MPL-F302026-08-21
00816848023008SUPRAMIDCode MPR-F40Code MPR-F402026-08-21
00816848023329SUPRAMID EXTRACode CL-F01Code CL-F012026-08-21
00816848023343SUPRAMID EXTRACode JC-F02Code JC-F022026-08-21
00816848023367SUPRAMIDCode MPR-F30Code MPR-F302026-08-21
00816848023381SUPRAMID EXTRACode JJ-F03Code JJ-F032026-08-21
00816848023527SUPRAMID EXTRACode LD-F08Code LD-F082026-08-21
00816848023541SUPRAMIDCode MCE-F20Code MCE-F202026-08-21
00816848023664SUPRAMID EXTRACode PL-F10Code PL-F102026-08-21
00816848023688SUPRAMID EXTRACode CL-F10Code CL-F102026-08-21
00816848023787SUPRAMID EXTRACode PL-F30Code PL-F302026-08-21
00816848023800SUPRAMID EXTRACode ACM-02Code ACM-022026-08-21
00816848023824SUPRAMID EXTRACode ACM-03Code ACM-032026-08-21
00816848023848SUPRAMID EXTRACode ACL-08Code ACL-082026-08-21
00816848023862SUPRAMIDCode MRL-F50Code MRL-F502026-08-21
00816848023886SUPRAMID EXTRACode PL-F40Code PL-F402026-08-21
00816848023947SUPRAMID EXTRACode CE-F20Code CE-F202026-08-21
00816848023954SUPRAMIDCode MSB-F50Code MSB-F502026-08-21
00816848024029SUPRAMIDCode MSB-F60Code MSB-F602026-08-21

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