FDA.reportPublic FDA data

SUPRAFOIL

Primary DI
00816848024074
Brand
SUPRAFOIL
Company
S JACKSON INC
Model
Code F-LSS-05
Catalog number
Code F-LSS-05
Device description
SupraFOIL Nylon Foil Implant, 9x10cm, 0.35mm thickness
Published
2024-08-28
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
10816848024071PackageGS14In Commercial Distribution
00816848024074PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081684802407110816848024071
00816848024074008168480240748168480240740816848024074

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
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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