FDA UDI
In Commercial Distribution
🇺🇸 United States
Patient Barrier Aprons
DI: 10732224004584
·
Model: NP4WH
·
CROSSTEX INTERNATIONAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Patient Barrier Aprons
- Primary DI
- 10732224004584
- Version / Model
- NP4WH
- Catalog Number
- NP4WH
- Company Name
- CROSSTEX INTERNATIONAL, INC.
- Labeler DUNS
- 057728685
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-09-15
- Public Version
- 1
- Public Version Date
- 2023-09-25
- Public Version Status
- New
- Public Device Record Key
- a82781c5-d87f-41cf-b578-a13ca2489a69
Device Description
Plastic, Knee Length (27 in x 44 in), White
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- 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 |
|---|---|---|---|---|
| KHR | ABSORBER, SALIVA, PAPER | Dental | 872.6050 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61048 | Patient examination/treatment drape, single-use | A non-sterile, noninvasive flat sheet designed to cover a portion of a patient’s anatomy during an examination or non-surgical treatment procedure in the home or healthcare facility primarily to prevent soiling/cross-contamination; it is not intended for surgical use. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10732224004584 | GS1 |
Customer Contacts
- Phone
- +1(585)359-0130
- [email protected]