FDA UDI
In Commercial Distribution
🇺🇸 United States
Medline
DI: 40080196496908
·
Model: SPT-2319CS
·
MEDLINE INDUSTRIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
80
Basic Information
- Brand Name
- Medline
- Primary DI
- 40080196496908
- Version / Model
- SPT-2319CS
- Catalog Number
- SPT-2319CS
- Company Name
- MEDLINE INDUSTRIES, INC.
- Labeler DUNS
- 025460908
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 80
- Record Status
- Published
- Publish Date
- 2018-09-30
- Public Version
- 1
- Public Version Date
- 2018-10-31
- Public Version Status
- New
- Public Device Record Key
- bfd45f9c-4107-47c6-a64a-1089a30387ae
Device Description
TBL CVR HD 50"X90" F/F
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| KKX | Drape, surgical | General, Plastic Surgery | 878.4370 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45021 | Instrument/equipment drape, single-use, sterile | A sterile device made of natural and/or synthetic flexible materials intended to be used as a non-dedicated protective covering for various surgical and/or non-surgical instruments/equipment [e.g., surgical tray, operating room (OR) equipment table, endoscope and endoscopic instruments, surgical cameras and lasers], to provide a barrier against cross-contamination in various clinical settings. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 40080196496908 | GS1 | ||||
| Unit of Use | 10080196496907 | GS1 |
Customer Contacts
- Phone
- +1(800)633-5463
- [email protected]