FDA UDI
In Commercial Distribution
🇺🇸 United States
XTRAC
DI: 010822602
·
Model: AL 8000 Ultra Plus
·
Strata Skin Sciences, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- XTRAC
- Primary DI
- 010822602
- Version / Model
- AL 8000 Ultra Plus
- Company Name
- Strata Skin Sciences, Inc.
- Labeler DUNS
- 618522536
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-02-13
- Public Version
- 4
- Public Version Date
- 2021-03-10
- Public Version Status
- Update
- Public Device Record Key
- 75862d31-7d03-4436-93f0-730b70fa1108
Device Characteristics
- Single Use
- No
- 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 Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | General, Plastic Surgery | 878.4810 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47228 | Nitrogen refillable cylinder | A container designed as a refillable cylinder used to hold compressed nitrogen (N2) under safe conditions at high pressure (e.g., 50 - 150 Bar). It is typically filled with nitrogen when delivered from the gas supplier and includes a valve stem, an opening/closing valve, and will be graded according to size (capacity) and colour-coded to denote nitrogen content. The cylinder is typically made of steel and must be used together with a pressure regulator in order to release the nitrogen at the correct working pressure. Nitrogen is typically used as a drive gas for surgical power tools (e.g., drills, reamers, saws) but can also be used in the clinical laboratory. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 010822602 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K041943 | 000 |