FDA UDI
In Commercial Distribution
🇺🇸 United States
MD Traction Rope
DI: 00840113230914
·
Model: 715000
·
ASPEN SURGICAL PRODUCTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- MD Traction Rope
- Primary DI
- 00840113230914
- Version / Model
- 715000
- Company Name
- ASPEN SURGICAL PRODUCTS, INC.
- Labeler DUNS
- 027680821
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-03-22
- Public Version
- 1
- Public Version Date
- 2021-03-30
- Public Version Status
- New
- Public Device Record Key
- ca70b3fe-a79c-4f98-8cbd-cd3eb108cfb1
Device Description
Intended to support and maintain the position of an anesthetized patient during surgery
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| 62664 | Traction cord | A length of synthetic fibre (e.g., nylon) intended to be used with a system of rope and pulleys, or a bed traction system, to apply traction forces during medical procedures (e.g., orthopaedic surgery, physical therapy). It is typically intended to be cut to the desired length, threaded around pulleys, and knotted where needed. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10840113230911 | GS1 | 50 | In Commercial Distribution | ||
| Primary | 00840113230914 | GS1 |
Customer Contacts
- Phone
- +1(616)698-7100
- [email protected]