FDA UDI
In Commercial Distribution
🇺🇸 United States
Poly-Tape 5 mm x 500 mm
DI: 05060267134295
·
Model: 102-1005
·
XIROS LTD
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Poly-Tape 5 mm x 500 mm
- Primary DI
- 05060267134295
- Version / Model
- 102-1005
- Catalog Number
- n/a
- Company Name
- XIROS LTD
- Labeler DUNS
- 228209805
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-10-10
- Public Version
- 1
- Public Version Date
- 2024-10-18
- Public Version Status
- New
- Public Device Record Key
- 8110f78a-5a06-4c17-a31f-d6693eb422d6
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
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FTL | Mesh, Surgical, Polymeric | General, Plastic Surgery | 878.3300 | 2 |
| QUW | Mesh, Surgical, Non-Resorbable, Orthopedics, Reinforcement Of Ligament | General, Plastic Surgery | 878.3300 | 2 |
| OWX | Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon | General, Plastic Surgery | 878.3300 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46242 | Surgical support tape, non-bioabsorbable | A band or cord intended to be used during surgery for the approximation, cerclage, fixation, retraction, ligation, and/or suspension of internal anatomical structures; some types may be used for connecting and supporting bone and/or ligaments and tendons. The device is typically made of a synthetic material (e.g., polyester, nylon, silicone) or cotton, is available in a variety of lengths and widths, and may be left in situ. This is a device that cannot be chemically degraded or absorbed via natural body processes. Disposable devices associated with implantation may be included. This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05060267134295 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K222978 | 000 |