FDA UDI
Not in Commercial Distribution
🇺🇸 United States
SchureMed
DI: 00810014603704
·
Model: 790-0040
·
SCHUERCH CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SchureMed
- Primary DI
- 00810014603704
- Version / Model
- 790-0040
- Company Name
- SCHUERCH CORPORATION
- Labeler DUNS
- 964322929
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-04-14
- Public Version
- 2
- Public Version Date
- 2021-05-26
- Public Version Status
- Update
- Public Device Record Key
- ea18d129-a0c9-4db4-acf5-cca67b39168e
- Distribution End Date
- 2021-05-24
Device Description
Schure Loc XPS Forearm Attachment
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 |
|---|---|---|---|---|
| 62639 | Upper-limb traction wrap/trap, reusable | A preformed device designed to encompass the fingers, hand or forearm to create a holder which can be attached to an external frame to provide traction/suspension of the upper limb during surgical procedures on the hand, arm or shoulder. It is typically made of metal or synthetic polymer materials (e.g., nylon) with self-retaining fasteners (e.g., Velcro), and may be used with a traction arm band and/or malleable metal stave which acts as the anchor to the traction frame; some types may be inflatable to provide grip by means of air pressure. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810014603704 | GS1 |
Customer Contacts
- Phone
- (781)982-7000
- [email protected]