FDA UDI
In Commercial Distribution
🇺🇸 United States
ArcTV™ Transvaginal Sling System
DI: 00860368002401
·
Model: A-TV-1001
·
UROCURE LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ArcTV™ Transvaginal Sling System
- Primary DI
- 00860368002401
- Version / Model
- A-TV-1001
- Catalog Number
- A-TV-1001
- Company Name
- UROCURE LLC
- Labeler DUNS
- 117159885
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-08-13
- Public Version
- 2
- Public Version Date
- 2022-06-10
- Public Version Status
- Update
- Public Device Record Key
- 2b39e4de-02c1-41c9-a345-a494ae9571d6
Device Description
ArcTV™ Transvaginal Sling System
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- MR Safe
- 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 |
|---|---|---|---|---|
| OTN | Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator | General, Plastic Surgery | 878.3300 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47986 | Female stress urinary incontinence surgical mesh-sling, synthetic polymer | A woven/knitted or porous strip of material made of non-bioabsorbable synthetic polymer (e.g., polypropylene) intended to be permanently implanted (via transobturator, transvaginal, retropubic or suprapubic approach) to support the urethra for the treatment of female stress urinary incontinence (SUI), resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD). It typically includes an integral adjustment suture which may contain bioabsorbable polymer materials. It may also be referred to as a tape or subfascial hammock. Disposable devices associated with implantation may be supplied with the mesh-sling. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860368002401 | GS1 |
Customer Contacts
- Phone
- 6124660117
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K183134 | 000 |