FDA UDI
In Commercial Distribution
🇺🇸 United States
Medline
DI: 10080196739424
·
Model: DYNJSD1035
·
MEDLINE INDUSTRIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Medline
- Primary DI
- 10080196739424
- Version / Model
- DYNJSD1035
- Catalog Number
- DYNJSD1035
- Company Name
- MEDLINE INDUSTRIES, INC.
- Labeler DUNS
- 025460908
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-14
- Public Version
- 4
- Public Version Date
- 2023-12-18
- Public Version Status
- Update
- Public Device Record Key
- f2a36b4f-3f27-4105-a4ce-eb6f2465fd56
Device Description
DRAPE,INCISE,6.5"X7.5",INVISISHIELD
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
- No
- Has Expiration Date
- Yes
- 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 |
|---|---|---|---|---|
| 62934 | Surgical dressing/drape kit, single-use | A collection of various types of patient drapes, dressings, covers and/or towels intended to be used to facilitate a surgical procedure. It does not include any pharmaceuticals, surgical instruments, surgical tubing, or mechanically functional devices and is not dedicated to catheterization support. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10080196739424 | GS1 | ||||
| Package | 40080196739425 | GS1 | CASE | 40 | In Commercial Distribution | |
| Package | 30080196739428 | GS1 | BOX | 10 | In Commercial Distribution |
Customer Contacts
- Phone
- +1(800)633-5463
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Avoid contact with an open flame or a high intensity heat source. Do not use in the presence of flammable anesthesia. Store at room temperature. Avoid execessive heat and shield from light.