FDA UDI
In Commercial Distribution
🇺🇸 United States
TAS Medical, Inc. Tissue Approximation System
DI: 00860011435907
·
Model: T-4000
·
TAS Medical, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- TAS Medical, Inc. Tissue Approximation System
- Primary DI
- 00860011435907
- Version / Model
- T-4000
- Catalog Number
- T-4000
- Company Name
- TAS Medical, Inc.
- Labeler DUNS
- 111249727
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-01-08
- Public Version
- 1
- Public Version Date
- 2024-01-16
- Public Version Status
- New
- Public Device Record Key
- 97beb2e0-a83c-47d1-8fb2-949445792fc8
Device Description
The Tissue Approximation System (TAS) consists of a polyamide (nylon) “zip-tie” attached to a braided polyethylene terephthalate (PET, or Dacron) leader to aid insertion. A one-way clasp allows for fixation of the tissue approximation without the need to tie surgical knots. When packaged for commercial distribution, four zip-ties with integrated suture leaders are accompanied by hand-held instruments that can be optionally used for insertion. The kit will be provided sterile within a polyethylene/Tyvek pouch.
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
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| GAR | Suture, Nonabsorbable, Synthetic, Polyamide | General, Plastic Surgery | 878.5020 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38000 | Nylon suture, non-bioabsorbable, monofilament | A single-strand (monofilament), synthetic, non-bioabsorbable thread made of nylon (a polyamide polymer) intended to join (i.e., approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues; it may include an attached disposable device(s) [e.g., needle, passer] intended to facilitate suture application. The thread provides temporary wound support until the wound sufficiently heals. It is not a barbed suture and does not include antimicrobial agents/materials. This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860011435907 | GS1 | ||||
| Previous | 00197644217267 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K220980 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 37 | Centimeter | |
| Width | 2.7 | Millimeter | |
| Height | 1.4 | Micrometer |