Smoltap
Infant Stabilizer Straps
1manufacturer
2catalogue 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 | Smoltap, Inc., United States |
|---|---|
| FDA product code | PRN |
| Device type | Pediatric Position Holder |
| Device class | Class 1 |
| Regulation | 21 CFR 880.5680 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-10-27 |
| Record revised | 2026-02-09 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Packaging | Box of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| STCR1 | In distribution | |
| STSTR1 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Inspired by Drive | Drive DeVilbiss Healthcare | 99 |
| Inspired | Drive DeVilbiss Healthcare | 84 |
| Coulmed | Coulmed Products Group LLC | 22 |
| 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 |
| 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.