FDA UDI
In Commercial Distribution
🇺🇸 United States
SRI Healthcare
DI: 00810019801570
·
Model: 128001
·
SRI Healthcare, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SRI Healthcare
- Primary DI
- 00810019801570
- Version / Model
- 128001
- Catalog Number
- 128001
- Company Name
- SRI Healthcare, LLC
- Labeler DUNS
- 117798086
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-06-24
- Public Version
- 1
- Public Version Date
- 2021-07-02
- Public Version Status
- New
- Public Device Record Key
- d93e4bb3-1c0e-401f-850b-545101e2b191
Device Description
Basic Pack, Towel
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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FRL | Fiber, Medical, Absorbent | General Hospital | 880.5300 | 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 |
|---|---|---|---|---|---|---|
| Primary | 00810019801570 | GS1 |
Customer Contacts
- Phone
- 8138919550
- [email protected]