FDA UDI
In Commercial Distribution
🇺🇸 United States
Medline
DI: 10080196740840
·
Model: DYNJP8412
·
MEDLINE INDUSTRIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Medline
- Primary DI
- 10080196740840
- Version / Model
- DYNJP8412
- Catalog Number
- DYNJP8412
- Company Name
- MEDLINE INDUSTRIES, INC.
- Labeler DUNS
- 025460908
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-02-08
- Public Version
- 2
- Public Version Date
- 2021-12-22
- Public Version Status
- Update
- Public Device Record Key
- 07c5cd73-d1d5-41f3-b2c6-e42bf751cb1e
Device Description
DRAPE,SHOULDER,BEACH CHAIR,STERILE
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
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| PUI | Drape, surgical, exempt | General, Plastic Surgery | 878.4370 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47783 | Patient surgical drape, single-use | A noninvasive sheet designed to cover a portion of a patient’s anatomy during a surgical procedure to function as a barrier to cross contamination (e.g., isolate a site of surgical incision, protect non-operative anatomy). It is not designed with specific heat-reflective or laser resistant materials. It is available in a variety of designs (e.g., flat sheet with or without an access hole, leg tube or an adhesive film sheet otherwise known as an incise drape). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 40080196740841 | GS1 | BOX | 5 | In Commercial Distribution | |
| Primary | 10080196740840 | GS1 |
Customer Contacts
- Phone
- +1(800)633-5463
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 105 | Inch | |
| Length | 159 | Inch |