FDA UDI
In Commercial Distribution
🇺🇸 United States
Athena Surgical RMUS System
DI: 00860003619810
·
Model: 9001-1
·
Athena Surgical LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Athena Surgical RMUS System
- Primary DI
- 00860003619810
- Version / Model
- 9001-1
- Company Name
- Athena Surgical LLC
- Labeler DUNS
- 117067792
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-07-30
- Public Version
- 2
- Public Version Date
- 2022-06-10
- Public Version Status
- Update
- Public Device Record Key
- 73ffa0b1-0105-480c-9dd2-c0a965064d8a
Device Description
Mid-Urethral Sling Assembly, Round Needles
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
- 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
- Yes
- Sterilization Methods
- Ethylene Oxide
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 |
|---|---|---|---|---|---|---|
| Package | 20860003619814 | GS1 | 3 | In Commercial Distribution | ||
| Primary | 00860003619810 | GS1 | ||||
| Package | 10860003619817 | GS1 | 15 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K210087 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 1.1 | Centimeter | |
| Length | 45 | Centimeter |