FDA UDI
In Commercial Distribution
🇺🇸 United States
CastWedge™
DI: G064208317270093041
·
Model: 20831727009304
·
Walgreen Health Solutions, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
20
Basic Information
- Brand Name
- CastWedge™
- Primary DI
- G064208317270093041
- Version / Model
- 20831727009304
- Catalog Number
- 20831727009304
- Company Name
- Walgreen Health Solutions, LLC
- Labeler DUNS
- 116685742
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 20
- Record Status
- Published
- Publish Date
- 2022-12-09
- Public Version
- 1
- Public Version Date
- 2022-12-19
- Public Version Status
- New
- Public Device Record Key
- 327a3be2-d284-49e3-87c3-9fc33472e4a6
Device Description
(30 mm) CastWedge™ Cast Adjuster. Designed for cast realignment and swelling relief. Use with plaster or fiberglass cast.
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
- Yes
- 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 |
|---|---|---|---|---|
| LGF | Component, Cast | Orthopedic | 888.5940 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66434 | Cast spreader, single-use | A hand-operated device intended to be used to adjust a plaster cast around a patient's limb or body part, typically for relief of post-operative swelling. It is in the form of a wedge with edges which is slid along the cast to maintain a precise opening and make exact adjustments to the cast. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | G064208317270093041 | HIBCC | ||||
| Unit of Use | G064208317270093040 | HIBCC |
Customer Contacts
- Phone
- 1-800-254-5438
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 30 | Millimeter |