FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Xenform™
DI: 08714729773764
·
Model: M0068302450
·
BOSTON SCIENTIFIC CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Xenform™
- Primary DI
- 08714729773764
- Version / Model
- M0068302450
- Company Name
- BOSTON SCIENTIFIC CORPORATION
- Labeler DUNS
- 021717889
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-09-24
- Public Version
- 3
- Public Version Date
- 2019-12-13
- Public Version Status
- Update
- Public Device Record Key
- c1d52235-d338-4a7c-87eb-b57b516d0787
- Distribution End Date
- 2019-07-23
Device Description
Soft Tissue Repair Matrix
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FTM | Mesh, surgical | General, Plastic Surgery | 878.3300 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61294 | Pelvic organ prolapse/stress urinary incontinence surgical mesh | A 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. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08714729773764 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 6 cm Length | ||
| Device Size Text, specify | 10 cm Length |