FDA.report

Xenform™

Primary DI
08714729774198
Brand
Xenform™
Company
BOSTON SCIENTIFIC CORPORATION
Model
M0068302470
Device description
Soft Tissue Repair Matrix
Published
2015-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
FTMMesh, surgical

Product Code Classifications

CodeDeviceSpecialtyClass
FTMMesh, SurgicalGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08714729774198PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08714729774198087147297741988714729774198

GMDN Terms

TermDefinition
Pelvic organ prolapse/stress urinary incontinence surgical meshA sterile woven/knitted or porous material comprised of bioabsorbable, animal-derived collagen, intended to be permanently implanted into a female patient for reinforcement and/or bridging of the supporting tissues of the pelvic floor to surgically treat vaginal pelvic organ prolapse (POP) [including anterior, posterior, or apical prolapse repair], and may alternatively be implanted to support the urethra to treat female stress urinary incontinence (SUI), resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD). It is typically available with various material attributes. Disposable devices associated with implantation (e.g., introducer needles) may be included.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Sterilization Methods

Method

Regulatory Flags

DUNS number
021717889
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 DIBrandModelCatalogPublished
08714729195573RotaWire™ and wireClip™ TorquerH802232390010H8022323900102014-09-24
08714729195566RotaWire™ and wireClip™ TorquerH802228240020H8022282400202014-09-24
08714729837527Stingray™H749M3004A02016-09-24
08714729877523EP XT™M0042007720M00420077202016-09-24
08714729877714Dynamic XT™M0042011120M00420111202016-09-24
08714729879947EP XT™M0046EPXT00390M0046EPXT003902016-09-24
08714729181088Percuflex™ BiliaryM005337602015-09-24
08714729181095Percuflex™ BiliaryM005337702015-09-24
08714729181101Percuflex™ BiliaryM005337802015-09-24
08714729181118Percuflex™ BiliaryM005337902015-09-24
08714729181125Percuflex™ BiliaryM005338002015-09-24
08714729181132Percuflex™ BiliaryM005338102015-09-24
08714729181149Percuflex™ BiliaryM005338202015-09-24
08714729181156Percuflex™ BiliaryM005338302015-09-24
08714729181163Percuflex™ BiliaryM005338502015-09-24
08714729181217Percuflex™ BiliaryM005336102015-09-24
08714729181224Percuflex™ BiliaryM005336202015-09-24
08714729181231Percuflex™ BiliaryM005336302015-09-24
08714729181248Percuflex™ BiliaryM005336402015-09-24
08714729181255Percuflex™ BiliaryM005336502015-09-24

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00812337020695Medeor Tendon MatrixDSM BIOMEDICAL, INC.FTM2026-03-24
00812337020701Medeor Tendon MatrixDSM BIOMEDICAL, INC.FTM2026-03-24
09421908222409Myriad Matrix™ Restore Restorative BioscaffoldAROA BIOSURGERY LIMITEDFTM2026-01-30
09421908222423Myriad Matrix™ Restore Restorative BioscaffoldAROA BIOSURGERY LIMITEDFTM2026-01-30
09421908222447Myriad Matrix™ Restore Restorative BioscaffoldAROA BIOSURGERY LIMITEDFTM2026-01-30
09421907331874OviTex® CoreAROA BIOSURGERY LIMITEDFTM2025-11-26
09421907331928OviTex® CoreAROA BIOSURGERY LIMITEDFTM2025-11-26
09421907331966OviTex® 1SAROA BIOSURGERY LIMITEDFTM2025-11-26
09421907331997OviTex® 1SAROA BIOSURGERY LIMITEDFTM2025-11-26
09421908222072OviTex® Low ProfileAROA BIOSURGERY LIMITEDFTM2025-11-26
09421908222089OviTex® Low ProfileAROA BIOSURGERY LIMITEDFTM2025-11-26
09421908222119OviTex® Low ProfileAROA BIOSURGERY LIMITEDFTM2025-11-26
09421908222126OviTex® Low ProfileAROA BIOSURGERY LIMITEDFTM2025-11-26
09421908222140OviTex® InguinalAROA BIOSURGERY LIMITEDFTM2025-11-26
09421908222263OviTex® Low ProfileAROA BIOSURGERY LIMITEDFTM2025-11-26
00850047730305Foundation DRS SoloBionova Medical Inc.FTM2025-09-17
00850047730312Foundation DRS SoloBionova Medical Inc.FTM2025-09-17
00850047730329Foundation DRS SoloBionova Medical Inc.FTM2025-09-17
00850047730336Foundation DRS SoloBionova Medical Inc.FTM2025-09-17
00850047730343Foundation DRS SoloBionova Medical Inc.FTM2025-09-17
00850038226008InvengenxTisgenx, Inc.FTM2025-05-28
00850038226015InvengenxTisgenx, Inc.FTM2025-05-28
00850038226022InvengenxTisgenx, Inc.FTM2025-05-28
00850038226039InvengenxTisgenx, Inc.FTM2025-05-28
00850038226046InvengenxTisgenx, Inc.FTM2025-05-28
00850038226053InvengenxTisgenx, Inc.FTM2025-05-28
00850038226060InvengenxTisgenx, Inc.FTM2025-05-28
00850038226077InvengenxTisgenx, Inc.FTM2025-05-28
00850038226084InvengenxTisgenx, Inc.FTM2025-05-28
00850038226091InvengenxTisgenx, Inc.FTM2025-05-28