Coulmed
Pediatric Gel Padded Ankle Straps for Candy Cane Stirrups, Size: 3/8' x 1-7/8' x 12-1/2', per pair
1manufacturer
22catalogue numbers in this listing
Who Else Makes It
Registered in Shandong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Lingxian Dongsheng Textile Co., Ltd. | Dezhou | Shandong | Contract manufacturer | 23 |
Record
| Listed by | Coulmed Products Group LLC, United States |
|---|---|
| FDA product code | PRN |
| Device type | Pediatric Position Holder |
| Device class | Class 1 |
| Regulation | 21 CFR 880.5680 |
| Establishment | Repacker / relabeller |
| Premarket notification | Exempt |
| Record published | 2023-01-06 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Packaging | Pack of 2 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| GP646 | In distribution | ||
| GP644 | In distribution | ||
| GP595 | In distribution | ||
| GP640 | In distribution | ||
| GP645 | In distribution | ||
| GP590 | In distribution | ||
| GP638 | In distribution | ||
| GP220 | In distribution | ||
| GP222 | In distribution | ||
| GP202 | In distribution | ||
| GP205 | In distribution | ||
| GP223 | In distribution | ||
| GP591 | In distribution | ||
| GP592 | In distribution | ||
| GP641 | In distribution | ||
| GP593 | In distribution | ||
| GP639 | In distribution | ||
| GP210 | In distribution | ||
| GP594 | In distribution | ||
| GP159-5 | 2 | In distribution | |
| GP221 | In distribution | ||
| GP637 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Inspired by Drive | Drive DeVilbiss Healthcare | 99 |
| Inspired | Drive DeVilbiss Healthcare | 84 |
| Domico Med-Device, LLC | Domico Med-Device, LLC | 4 |
| Medline | Medline Industries, Inc. | 2 |
| MedibinoNEO disposable cover cotton knit With soft granules – Size L – PU 50 | Kluba Medical GmbH | 2 |
| Smoltap | Smoltap, Inc. | 2 |
| Danny Sling 5-9 LBS | Bird & Cronin, LLC | 1 |
| Danny Sling 10-18 LBS | Bird & Cronin, LLC | 1 |
| Kerry Kuddler 18-40 LBS | Bird & Cronin, LLC | 1 |
| Danny Sling 2-5 LBS | Bird & Cronin, LLC | 1 |
| Voss 7″ Round Support | VM/Positioning, Inc. | 1 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.