FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Xcel
DI: 07613154092604
·
Model: 3910-300-015
·
STRYKER CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Xcel
- Primary DI
- 07613154092604
- Version / Model
- 3910-300-015
- Catalog Number
- 3910-300-015
- Company Name
- STRYKER CORPORATION
- Labeler DUNS
- 187502109
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-09-08
- Public Version
- 7
- Public Version Date
- 2022-12-12
- Public Version Status
- Update
- Public Device Record Key
- 2a9a3705-aad5-412b-b1d2-7d568ed8b57c
- Distribution End Date
- 2022-12-11
Device Description
3MM XCEL WITH 1 STRAND #2 FORCE FIBER
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
- 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 |
|---|---|---|---|---|
| MAI | FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE | Orthopedic | 888.3030 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45061 | Tendon/ligament bone anchor, bioabsorbable | A bioabsorbable device designed to be implanted into bone for the attachment of tendons/ligaments/soft tissues either directly or via a suture attached to the device; typically used in arthroscopic or open surgical procedures. This device is available in various designs and sizes and is made of a material that can be chemically degraded and typically absorbed via natural body processes (e.g., a copolymer, metal alloy). | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 37613154092605 | GS1 | pack | 5 | Not in Commercial Distribution | 2022-12-11 |
| Primary | 07613154092604 | GS1 |
Customer Contacts
- Phone
- +1(866)624-4422
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K041307 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Diameter: 3.0 Millimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- High: 54 Degrees Celsius
- Type
- Handling Environment Temperature
- Temperature Range
- High: 54 Degrees Celsius