FDA UDI
In Commercial Distribution
🇺🇸 United States
Schaerer Medical USA
DI: 00810101301032
·
Model: 92036-3
·
Schaerer Medical Usa, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Schaerer Medical USA
- Primary DI
- 00810101301032
- Version / Model
- 92036-3
- Catalog Number
- 92036-3
- Company Name
- Schaerer Medical Usa, Inc.
- Labeler DUNS
- 092820703
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-09-16
- Public Version
- 1
- Public Version Date
- 2022-09-26
- Public Version Status
- New
- Public Device Record Key
- 781d827e-048e-4b0f-bee3-2ab46b82d3f1
Device Description
ARCUS PELVIC BASE PAD 3"
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
- 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 |
|---|---|---|---|---|
| FWZ | Operating Room Accessories Table Tray | General, Plastic Surgery | 878.4950 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62650 | Operating table torso positioner | A preformed device (e.g., cushion, foam pad, lateral post, bolster, wedge, multi-jointed metal structure) designed to be attached to an operating table for stabilizing a patient's body trunk (e.g., shoulders, chest, pelvis, hips) to adequately position, support, and reduce pressure on the bony prominences of the body part during intraoperative procedures (e.g., orthopaedic surgery). It is typically used when the patient is in the prone, lateral, or Trendelenburg position; it may be adhesive or components for attachment to the operating table (e.g., adaptors, straps) may be included with the device. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810101301032 | GS1 |
Customer Contacts
- Phone
- 1-800-755-6381
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Height | 3 | Inch |