FDA UDI
In Commercial Distribution
🇺🇸 United States
Active Heel Traction Boot
DI: 00885554024845
·
Model: 72203345
·
Smith & Nephew, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Active Heel Traction Boot
- Primary DI
- 00885554024845
- Version / Model
- 72203345
- Catalog Number
- 72203345
- Company Name
- Smith & Nephew, Inc.
- Labeler DUNS
- 045483575
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-07-20
- Public Version
- 4
- Public Version Date
- 2023-09-07
- Public Version Status
- Update
- Public Device Record Key
- d8d08e8c-f71a-4f3e-a02d-e1bedad45f7c
Device Description
ACTIVE HEEL TRACTION BOOT REPLACEMENT KIT -TOE STRAP
Device Characteristics
- Single Use
- No
- 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HST | APPARATUS, TRACTION, NON-POWERED | Orthopedic | 888.5850 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35547 | Heel stirrup cushion/pad | A pad designed to be placed between a patient's foot and a table heel stirrup, cushioning the patient's heel and lower leg to provide greater comfort and to reduce the risk of sores during long procedures. The device is typically made of soft material (e.g., foam) with an appropriate shape and size to fit the heel stirrup; it is usually supplied in pairs. The device is used mainly for patients in lithotomic position for obstetrical, urological, colonic, or rectal procedures. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00885554024845 | GS1 |
Customer Contacts
- Phone
- +1(800)238-7538
- [email protected]