FDA UDI
In Commercial Distribution
🇺🇸 United States
Pad Steris C-Max,4085 & 5085 2 Thick (Set Of 3)
DI: B337BBCMAX1
·
Model: BBCMAX
·
FUTURE HEALTH CONCEPTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Pad Steris C-Max,4085 & 5085 2 Thick (Set Of 3)
- Primary DI
- B337BBCMAX1
- Version / Model
- BBCMAX
- Catalog Number
- BBCMAX
- Company Name
- FUTURE HEALTH CONCEPTS, INC.
- Labeler DUNS
- 037304144
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-09-16
- Public Version
- 1
- Public Version Date
- 2020-09-24
- Public Version Status
- New
- Public Device Record Key
- 8d3a0766-6f1d-4dcd-9fa8-30ee2e582a7b
Device Description
Steris C-Max, 4085 & 5085 Operating Room Table Pad 2 Thick (Set Of 3). 2860 High-Density Polyurethane Foam Non-Latex With Conductive Vinyl Sheeting Top And Bottom Cover With Velcro Kit. This Pad Is Recommended For Shorter Procedures.
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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LWG | Surgical Table Cushion | General, Plastic Surgery | 878.4950 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36063 | Stretcher mattress | A large, flat, cushion or pad with a strong cover filled with a resilient material (e.g., foam rubber) designed to be used on a stretcher to provide patient comfort whilst they lie upon it. It is much thinner than a bed mattress and is placed on top of, and typically secured to, the stretcher support platform covering this area. This is a general-purpose device that has no special therapeutic purpose. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B337BBCMAX1 | HIBCC |