Couture 640304
GUDID 00078301640348
Carolon Company
Compression/pressure sock/stocking, reusable| Primary Device ID | 00078301640348 |
| NIH Device Record Key | a9f8323b-f085-4568-a07f-e4c2062678ff |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Couture |
| Version Model Number | Armsleeve |
| Catalog Number | 640304 |
| Company DUNS | 061789731 |
| Company Name | Carolon Company |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | MR Safe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | true |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00078301640348 [Primary] |
FDA Product Code
| FQL | Stocking, Medical Support (For General Medical Purposes) |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-01-31 |
| Device Publish Date | 2024-01-23 |
On-Brand Devices [Couture]
Trademark Results [Couture]
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.