FDA UDI
In Commercial Distribution
🇺🇸 United States
SchureMed
DI: 00810014604701
·
Model: 508-0154
·
SCHUERCH CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SchureMed
- Primary DI
- 00810014604701
- Version / Model
- 508-0154
- Company Name
- SCHUERCH CORPORATION
- Labeler DUNS
- 964322929
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-09-21
- Public Version
- 2
- Public Version Date
- 2021-07-15
- Public Version Status
- Update
- Public Device Record Key
- bc7c37a9-961e-45b8-b19a-a43c4a772182
Device Description
Knee Crutch Pads
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
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| 11062 | Crutch pad | A formed piece of non-slip material (e.g., rubber, glycerin gel, sheepskin) designed to be attached to a part of a crutch to enable firm and comfortable support during use of the crutch, e.g., for use with an axillary crutch or elbow crutch. A crutch will typically be initially provided with the necessary padding, this meaning that this GMDN code serves products meant as replacement parts or for additional crutch padding. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810014604701 | GS1 |
Customer Contacts
- Phone
- (781)982-7000
- [email protected]