FDA.reportPublic FDA data

Proformix

Primary DI
M070PR04071
Brand
Proformix
Company
STELLEN MEDICAL, LLC
Model
PR-0407
Catalog number
PR-04074
Device description
Multi-purpose implantable surgical mesh, collagen, bioabsorbable-for use in procedures such as achilles repair, rotator cuff and ligaments.
Published
2015-04-01
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M070PR04071PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Extra-gynaecological surgical mesh, collagen, bioabsorbableA bioabsorbable, implantable material (e.g., flat sheet) made from animal-derived collagen intended for extra-gynaecological, non-dental tissue repair/reinforcement application(s) [e.g., pericardial reinforcement, plastic surgery, abdominal hernia repair]. It is constructed of cross-linked collagen (e.g., with glutaraldehyde) and may also be intended as a short-term scaffold for tissue regeneration. Disposable devices associated with implantation may be supplied with the mesh.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity0 Degrees Fahrenheit77 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
651-426-1496customerservice@stellenmedical.com

Regulatory Flags#

DUNS number
801160037
Device count
1
DM exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00855638007125Nova GelGEL-6505GEL-65052020-10-22
M070PR02051ProformixPR-0205PR-02052015-04-01
M070PR05101ProformixPR-0510PR-05102015-04-01
00855638007002ProLayer Xenograft3102-21252017-07-06
00855638007019ProLayer Xenograft3102-21442017-07-06
00855638007026ProLayer Xenograft3102-21472017-07-06
00855638007033ProLayer Xenograft3102-21512017-07-06
00855638007064GlucanPro 3000GPC3-0180GPC3-01802020-10-22
00855638007088GlucanPro GPC-0085GPC-00852020-10-22
00855638007101GlucanPro GPC-0025GPC-00252020-10-22
00855638007040GlucanPro 3000GPC3-0035GPC3-00352020-10-22
00855638007149Brennen Skin Graft Mesher1:12022-08-10
00855638007156Brennen Skin Graft Mesher6:12022-08-10
00855638007163Brennen Skin Graft Mesher4:12022-08-10
00855638007170Brennen Skin Graft Mesher3:12022-08-10
00855638007187Brennen Skin Graft Mesher2:12022-08-10
00855638007194Brennen Skin Graft MesherPC2022-08-10
00855638007071GlucanPro 3000GPC3-0180GPC3-01802020-10-22
00855638007095GlucanPro GPC-0085GPC-00852020-10-22
00855638007118GlucanPro GPC-0025GPC-00252020-10-22

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