FDA.reportPublic FDA data

ProLayer Xenograft

Primary DI
00855638007019
Brand
ProLayer Xenograft
Company
STELLEN MEDICAL, LLC
Model
3102-2144
Device description
Acellular Dermal Matrix
Published
2017-07-06
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
00855638007019PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00855638007019008556380070198556380070190855638007019

GMDN Terms#

Term, Definition table
TermDefinition
Multi-purpose surgical mesh, collagen, bioabsorbableA sterile, bioabsorbable, flat or three-dimensional (3-D) implantable material made from animal-derived collagen intended for multiple tissue defect repair/hernia reduction (e.g., inguinal, ventral/incisional, umbilical, femoral) applications including an extra-abdominal application(s) [e.g., plastic surgery, breast reconstruction]. It may also be used as a short-term scaffold for tissue regeneration. Disposable devices associated with implantation (e.g., introducer needles, trocars) may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length4Centimeter
Width4Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Fahrenheit77 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-943-4520customerservice@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
M070PR04071ProformixPR-0407PR-040742015-04-01
M070PR05101ProformixPR-0510PR-05102015-04-01
00855638007002ProLayer Xenograft3102-21252017-07-06
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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Primary DI, Brand, Company table
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00802526629938CanGaroo®Boston Scientific CorporationFTM2026-05-27
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