FDA UDI
Not in Commercial Distribution
🇺🇸 United States
SteriGear
DI: 02618125177576
·
Model: 27605
·
TIDI PRODUCTS, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- SteriGear
- Primary DI
- 02618125177576
- Version / Model
- 27605
- Company Name
- TIDI PRODUCTS, LLC
- Labeler DUNS
- 063519193
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-03-29
- Public Version
- 6
- Public Version Date
- 2023-02-28
- Public Version Status
- Update
- Public Device Record Key
- 0730ff2a-0e95-4b13-9d2c-beba66980041
- Distribution End Date
- 2023-02-27
Device Description
Microscope Drapes Clear Polyethylene Sterile 54in x 120in 10 per Case
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
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EPT | Microscope, Surgical | General, Plastic Surgery | 878.4700 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 12535 | Medical equipment drape, single-use | A flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or equipment components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the contents from soiling and contamination when used in the vicinity of, or entered into, a hygienic area. It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00618125177578 | GS1 | 2 | Not in Commercial Distribution | 2023-02-27 | |
| Package | 01618125177577 | GS1 | 5 | Not in Commercial Distribution | 2023-02-27 | |
| Primary | 02618125177576 | GS1 |