FDA UDI
In Commercial Distribution
🇺🇸 United States
McConnell Orthopedic MFG. CO.
DI: 00860013953560
·
Model: 12-215
·
MCCONNELL ORTHOPEDIC MFG. CO.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- McConnell Orthopedic MFG. CO.
- Primary DI
- 00860013953560
- Version / Model
- 12-215
- Catalog Number
- 12-215
- Company Name
- MCCONNELL ORTHOPEDIC MFG. CO.
- Labeler DUNS
- 174128843
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-05-02
- Public Version
- 1
- Public Version Date
- 2025-05-12
- Public Version Status
- New
- Public Device Record Key
- e811f132-8504-4e1a-b972-56a4d53782f4
Device Description
Large Hand Wrap (Box of 10)
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| CCX | Support, Patient Position | Anesthesiology | 868.6820 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62638 | Upper-limb traction wrap/trap, single-use | 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 synthetic polymer textile (e.g., nylon) and includes self-retaining fasteners (e.g., Velcro); it may be used with a traction arm band and/or malleable metal stave which acts as the anchor to the traction frame. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860013953560 | GS1 |
Customer Contacts
- Phone
- 9034550321
- [email protected]