FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Align® TO Trans-Obturator Urethral Support System - Hook & Halo without Dilator
DI: 00801741016240
·
Model: BRD601HH
·
C. R. Bard, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Align® TO Trans-Obturator Urethral Support System - Hook & Halo without Dilator
- Primary DI
- 00801741016240
- Version / Model
- BRD601HH
- Catalog Number
- BRD601HH
- Company Name
- C. R. Bard, Inc.
- Labeler DUNS
- 016898496
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-09-14
- Public Version
- 4
- Public Version Date
- 2022-06-10
- Public Version Status
- Update
- Public Device Record Key
- 6ec90172-dbf9-4c7c-a6d7-524a36669a10
- Distribution End Date
- 2016-12-31
Device Description
ALIGN® TO Urethral Support System, Hook & Halo w/o dilator
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
- 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 |
|---|---|---|---|---|
| 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 | 00801741016240 | GS1 | ||||
| Package | 10801741016247 | GS1 | Other | 1 | Not in Commercial Distribution | 2016-12-31 |
Customer Contacts
- Phone
- +1(800)526-4455
- [email protected]