FDA UDI
In Commercial Distribution
🇺🇸 United States
XtractSR
DI: 05060766500140
·
Model: 72120
·
T.S.G. ASSOCIATES LLP
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- XtractSR
- Primary DI
- 05060766500140
- Version / Model
- 72120
- Catalog Number
- 72120
- Company Name
- T.S.G. ASSOCIATES LLP
- Labeler DUNS
- 211458967
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-09-04
- Public Version
- 1
- Public Version Date
- 2024-09-12
- Public Version Status
- New
- Public Device Record Key
- 0dae90d8-e76e-4ff3-aa32-ff31616c5587
Device Description
Xtract™SR Module - 72120
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- Yes
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FPP | Stretcher, Hand-Carried | General Hospital | 880.6900 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 13818 | Portable stretcher | A manual device in the form of a portable lightweight platform or sheet with handles on which a patient can be carried in an emergency from an area inaccessible to a conventional ambulance stretcher. It may be designed as a folding stretcher, rescue backet, spine board, or evacuation sheet, and may include patient straps to secure/stabilize the patient. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05060766500140 | GS1 |