FDA UDI
Not in Commercial Distribution
🇺🇸 United States
ASP MEDICAL
DI: 00840216102576
·
Model: GNTP202
·
Asp Global, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ASP MEDICAL
- Primary DI
- 00840216102576
- Version / Model
- GNTP202
- Company Name
- Asp Global, LLC
- Labeler DUNS
- 080361159
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-07-02
- Public Version
- 2
- Public Version Date
- 2023-03-20
- Public Version Status
- Update
- Public Device Record Key
- 6421aeab-2b2c-486e-b68b-e28ec34adb15
- Distribution End Date
- 2023-03-17
Device Description
COVERALL, BLUE SMS XL, WITH POCKETS, ZIPPER FRONT NON AMII 1/EA, 5/BG, 50/CS
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- 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 |
|---|---|---|---|---|
| LYU | Accessory, Surgical Apparel | General, Plastic Surgery | 878.4040 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65414 | Surgical coverall | A single-piece, fluid-resistant garment intended to be worn by healthcare staff over a scrub suit to cover the arms, trunk, legs, and head during a surgical procedure or for other appropriate medical reasons. Also known as a jump suit, it is used to help protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material; it may include separate shoe covers. This is a single-use garment. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840216102576 | GS1 |