FDA UDI
In Commercial Distribution
🇺🇸 United States
Lac-Mac
DI: 00627755250698
·
Model: 075XVAB
·
Lac-Mac Limited
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Lac-Mac
- Primary DI
- 00627755250698
- Version / Model
- 075XVAB
- Catalog Number
- 075XVAB
- Company Name
- Lac-Mac Limited
- Labeler DUNS
- 201276334
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-05-28
- Public Version
- 6
- Public Version Date
- 2021-02-05
- Public Version Status
- Update
- Public Device Record Key
- e10f89db-f2a5-4292-acd4-28abfb82af5b
Device Description
Mayo Stand Cover, 53 X 27, Level 4, Customer Supplied Barcode in specified location
Device Characteristics
- Single Use
- No
- 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
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
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 |
|---|---|---|---|---|
| 47780 | Patient surgical drape, reusable | 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). This is a reusable device intended to be sterilized prior to use. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00627755250698 | GS1 |
Customer Contacts
- Phone
- 5194322616
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K031362 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Height | 27 | Inch | |
| Width | 53 | Inch |