| Primary Device ID | 00817612020353 |
| NIH Device Record Key | 7aad538e-272d-4e59-a232-7e3235f75f99 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Dale Bendable Armboard |
| Version Model Number | 653 |
| Catalog Number | 653 |
| Company DUNS | 001061233 |
| Company Name | DALE MEDICAL PRODUCTS, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | MR Conditional |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00817612020346 [Primary] |
| GS1 | 00817612020353 [Package] Contains: 00817612020346 Package: Box [10 Units] In Commercial Distribution |
| HIBCC | H84106531 [Previous] |
| FYH | Splint, Extremity, Noninflatable, External, Sterile |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2019-05-15 |
| Device Publish Date | 2019-02-19 |
| 00817612020353 | Dale Bendable Armboard, X-Small, 4.25" x 1" |
| H84106521 | Dale Bendable Armboard, Small, 4.5" x 1.75" |
| H84106511 | Dale Bendable Armboard, Medium, 5.38" x 2.5" |
| H84106501 | Dale Bendable Armboard, Large, 9" x 3.5" |
| H84106532 | Dale Bendable Armboard, X-Small, 4.25" x 1" |
| H84106522 | Dale Bendable Armboard, Small, 4.5" x 1.75" |
| H84106512 | Dale Bendable Armboard, Medium, 5.38" x 2.5" |