FDA UDI
In Commercial Distribution
🇺🇸 United States
Kumar T-ANCHORS® Hernia Set
DI: B361TA0080
·
Model: TA-008
·
NASHVILLE SURGICAL INSTRUMENTS, LLC
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Kumar T-ANCHORS® Hernia Set
- Primary DI
- B361TA0080
- Version / Model
- TA-008
- Catalog Number
- TA-008
- Company Name
- NASHVILLE SURGICAL INSTRUMENTS, LLC
- Labeler DUNS
- 030096122
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-08-15
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 249d5644-0438-4f20-939f-208e885bbe8c
Device Description
The Kumar T-ANCHORS® Hernia Set provides a means of Fixation of the Mesh in Laparoscopic or Open Repair of Abdominal Wall Hernia as Trans-fascial sutures, in addition to the tackers. Kumar T-ANCHORS® eliminate the need for grasping and feeding of sutures into a Suture Passer.
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
- Yes
- MRI Safety
- MR Safe
- Direct Marking Exempt
- Yes
- 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 |
|---|---|---|---|---|
| GDW | Staple, Implantable | General, Plastic Surgery | 878.4750 | 2 |
| GAR | Suture, Nonabsorbable, Synthetic, Polyamide | General, Plastic Surgery | 878.5020 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62844 | Surgical mesh T fastener | An implantable device intended to be inserted percutaneously across the abdominal wall for trans-fascial fixation of a surgical mesh in the treatment of abdominal hernia. It consists of a metal T-bar with an attached non-bioabsorbable polymer suture, and includes appropriate introduction devices (e.g., needle, pusher stylet). | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B361TA0080 | HIBCC | ||||
| Package | B361TA0081 | HIBCC | Box | 10 | In Commercial Distribution |
Customer Contacts
- Phone
- 615-382-4996
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K081366 | 000 |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 30 – 70 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 45 – 85 Degrees Fahrenheit