FDA UDI
In Commercial Distribution
🇺🇸 United States
ASP Medical
DI: 00840216101784
·
Model: OTT406
·
Asp Global, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- ASP Medical
- Primary DI
- 00840216101784
- Version / Model
- OTT406
- Company Name
- Asp Global, LLC
- Labeler DUNS
- 080361159
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-08-02
- Public Version
- 1
- Public Version Date
- 2022-08-10
- Public Version Status
- New
- Public Device Record Key
- 835d8a36-443d-4d6f-8c49-790cb1564ac7
Device Description
OR TOWEL, STERILE, BLUE EACH
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
- No
- 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 |
|---|---|---|---|---|
| KKK | Sudan Iv | Hematology | 864.1850 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 14077 | Surgical towel | A sterile cloth used in the operating room (OR) to absorb extraneous fluids. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10840216101781 | GS1 | Inner Pack | 6 | In Commercial Distribution | |
| Primary | 00840216101784 | GS1 | ||||
| Package | 20840216101788 | GS1 | Case | 12 | In Commercial Distribution |