FDA.reportPublic FDA data

SUPRAFOIL

Primary DI
10816848022909
Brand
SUPRAFOIL
Company
S JACKSON INC
Model
Code F-SS-035
Catalog number
Code F-SS-035
Device description
SupraFOIL Nylon Foil Implant, 4x4cm, 0.35mm thickness
Published
2017-08-09
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
10816848022909PackageGS16In Commercial Distribution
00816848022902PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081684802290910816848022909
00816848022902008168480229028168480229020816848022902

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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00802526629907CanGaroo®Boston Scientific CorporationFTM2026-05-27
00802526629914CanGaroo®Boston Scientific CorporationFTM2026-05-27
00802526629921CanGaroo®Boston Scientific CorporationFTM2026-05-27
00802526629938CanGaroo®Boston Scientific CorporationFTM2026-05-27
00802526629945CanGaroo®Boston Scientific CorporationFTM2026-05-27
00802526630002EluPro™Boston Scientific CorporationFTM2026-05-27
00802526630019EluPro™Boston Scientific CorporationFTM2026-05-27
09421908222393Myriad Matrix™ Restore Restorative BioscaffoldAROA BIOSURGERY LIMITEDFTM2026-01-30
09421908222416Myriad Matrix™ Restore Restorative BioscaffoldAROA BIOSURGERY LIMITEDFTM2026-01-30
09421908222430Myriad Matrix™ Restore Restorative BioscaffoldAROA BIOSURGERY LIMITEDFTM2026-01-30
09421908222454Myriad Matrix™ Restore Restorative BioscaffoldAROA BIOSURGERY LIMITEDFTM2026-01-30
09421907331881OviTex® CoreAROA BIOSURGERY LIMITEDFTM2025-11-26
09421907331935OviTex® 1SAROA BIOSURGERY LIMITEDFTM2025-11-26
09421907331942OviTex® 1SAROA BIOSURGERY LIMITEDFTM2025-11-26
09421907331959OviTex® 1SAROA BIOSURGERY LIMITEDFTM2025-11-26
09421907331973OviTex® 1SAROA BIOSURGERY LIMITEDFTM2025-11-26
09421908222065OviTex® 2SAROA BIOSURGERY LIMITEDFTM2025-11-26
09421908222096OviTex® Low ProfileAROA BIOSURGERY LIMITEDFTM2025-11-26
09421908222102OviTex® Low ProfileAROA BIOSURGERY LIMITEDFTM2025-11-26
09421908222157OviTex® InguinalAROA BIOSURGERY LIMITEDFTM2025-11-26
00859389005331EluPro Antibiotic-Eluting BioEnvelopeElutia Med LLCFTM2024-09-06
00859389005348EluPro Antibiotic-Eluting BioEnvelopeElutia Med LLCFTM2024-09-06
B454VSC10VersaWrapAlafair Biosciences, Inc.FTM2024-06-10
09421906661903OviTex® IHRAROA BIOSURGERY LIMITEDFTM2024-03-21
09421906661910OviTex® IHRAROA BIOSURGERY LIMITEDFTM2024-03-21
09421906661927OviTex® IHRAROA BIOSURGERY LIMITEDFTM2024-03-21
09421906661880Myriad Ultra™ Reinforced BioScaffold – Permanent (PP)AROA BIOSURGERY LIMITEDFTM2022-11-28
09421906661897Myriad Ultra™ Reinforced BioScaffold – Permanent (PP)AROA BIOSURGERY LIMITEDFTM2022-11-28
09421906017670Myriad Matrix™ Soft Tissue BioscaffoldAROA BIOSURGERY LIMITEDFTM2022-04-01
09421906017663Myriad Matrix™ Soft Tissue BioscaffoldAROA BIOSURGERY LIMITEDFTM2022-03-23