FDA UDI
In Commercial Distribution
🇺🇸 United States
Imperial Replacement mat
DI: 07540162040504
·
Model: OR-36363-1A
·
Imperial Surgical Ltd
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Imperial Replacement mat
- Primary DI
- 07540162040504
- Version / Model
- OR-36363-1A
- Catalog Number
- OR-36363-1A
- Company Name
- Imperial Surgical Ltd
- Labeler DUNS
- 245253575
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-07-28
- Public Version
- 1
- Public Version Date
- 2023-08-07
- Public Version Status
- New
- Public Device Record Key
- 512d167a-a5ae-460e-8db4-1ca964f8b6fa
Device Description
Replacement Pad
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
- 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
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FZM | Stool, Operating-Room | General, Plastic Surgery | 878.4950 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64493 | Anti-fatigue floor mat | A pad designed to be stood on by healthcare staff to reduce fatigue associated with standing for prolonged periods (e.g., during procedures). It is designed to cushion the feet of the user and may include additional secondary features (e.g., non-slip, antimicrobial surface). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07540162040504 | GS1 |
Customer Contacts
- Phone
- 514-631-7988
- [email protected]