FDA UDI
Not in Commercial Distribution
🇺🇸 United States
6 mm x 23 mm Fastlok plus 2 Ortho-Tapes (3mm x 400mm)
DI: 05060267130587
·
Model: 102-1354
·
XIROS LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- 6 mm x 23 mm Fastlok plus 2 Ortho-Tapes (3mm x 400mm)
- Primary DI
- 05060267130587
- Version / Model
- 102-1354
- Catalog Number
- n/a
- Company Name
- XIROS LTD
- Labeler DUNS
- 228209805
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-10-09
- Public Version
- 11
- Public Version Date
- 2026-04-13
- Public Version Status
- Update
- Public Device Record Key
- 90cacc49-be56-41ea-b1b4-16f98fb1bf2a
- Distribution End Date
- 2024-12-01
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
- MR Conditional
- 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 |
|---|---|---|---|---|
| JDR | Staple, Fixation, Bone | Orthopedic | 888.3030 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 13906 | Polyester suture, non-bioabsorbable, multifilament, non-antimicrobial | A multiple-strand (multifilament), synthetic thread made from a non-bioabsorbable polyester 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 to withstand normal stress. 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 | 05060267130587 | GS1 |
Customer Contacts
- Phone
- +4401132387202
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K010051 | 000 |