FDA.reportPublic FDA data

SUPRAFOIL

Primary DI
10816848023913
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
OTC
false
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 rim prosthesisA sterile implantable ocular device used to reconstruct the floor of the bony cavity that contains the eyeball and its associated muscles, vessels, and nerves, (i.e., the orbital floor and/or rim of the eye socket), and is intended to house an artificial eye. 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8003685225sales@supramid.com

Regulatory Flags#

DUNS number
069277028
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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816848020007SUPRAMID EXTRACode 2CR-30Code 2CR-30-W2017-08-07
00816848020014SUPRAMID EXTRACode 2CR-40Code 2CR-40-W2017-08-07
00816848020021SUPRAMID EXTRACode 2EA-40Code 2EA-40-W2017-08-07
00816848020038SUPRAMID EXTRACode 2ER-20Code 2ER-20-W2017-08-07
00816848020045SUPRAMID EXTRACode 2ER-30Code 2ER-30-W2017-08-07
00816848020052SUPRAMID EXTRACode 2ER-40Code 2ER-40-W2017-08-07
00816848020069SUPRAMID EXTRACode 2FO-40Code 2FO-40-W2017-08-07
00816848020076SUPRAMID EXTRACode 2GS-1-30Code 2GS-1-30-W2017-08-07
00816848020083SUPRAMID EXTRACode 2GS-2-30Code 2GS-2-30-W2017-08-07
00816848020090SUPRAMID EXTRACode 2JB-20BCode 2JB-20B2017-08-08
00816848020106SUPRAMID EXTRACode 2JB-20Code 2JB-20-W2017-08-08
00816848020113SUPRAMID EXTRACode 2LA-40Code 2LA-40-W2017-07-24
00816848020120SUPRAMID EXTRACode 2LC-30Code 2LC-30-W2017-08-08
00816848020137SUPRAMID EXTRACode 2LC-40Code 2LC-40-W2017-08-08
00816848020144SUPRAMID EXTRACode 2LC-40BCode 2LC-40B2017-07-24
00816848020199SUPRAMID EXTRACode 2OS-40Code 2OS-40W2017-08-08
00816848020205SUPRAMID EXTRACode 2S-1-30Code 2S-1-30W2017-08-08
00816848020212SUPRAMID EXTRACode 2S-1-40Code 2S-1-40W2017-08-08
00816848020236SUPRAMID EXTRACode 2S-2-40Code 2S-2-40W2017-08-08
00816848020243SUPRAMID EXTRACode 2VN-40Code 2VN-40W2017-08-08

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