FDA UDI
In Commercial Distribution
🇺🇸 United States
Medline-Microtek
DI: 00748426142880
·
Model: Patient Drapes
·
Microtek Medical LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Medline-Microtek
- Primary DI
- 00748426142880
- Version / Model
- Patient Drapes
- Catalog Number
- 2993
- Company Name
- Microtek Medical LLC
- Labeler DUNS
- 106908437
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-06-09
- Public Version
- 1
- Public Version Date
- 2025-06-17
- Public Version Status
- New
- Public Device Record Key
- 7103edb8-a480-4092-b88d-6068640f6367
Device Description
Patient Drape, Under Buttocks Drape, 99 cm x 88 cm (39 in x 35 in)
Device Characteristics
- Single Use
- Yes
- 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
- 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
- Yes
- Sterilization Methods
- Ethylene Oxide
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 |
|---|---|---|---|---|
| 46683 | Rigid endoscopic cytology brush, single-use | A sterile device intended to be used in combination with a compatible rigid endoscope to collect cells of the mucosa for pathological diagnosis during endoscopy. It is inserted through the working channel of the endoscope and consists of a rigid insertion portion made of a metal coil or plastic tube, whose distal end is equipped with plastic bristles for harvesting mucosal cells. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10748426142887 | GS1 | Pack | 10 | In Commercial Distribution | |
| Primary | 00748426142880 | GS1 | ||||
| Package | 20748426142884 | GS1 | Case | 2 | In Commercial Distribution |