| Primary Device ID | 00628347062774 |
| NIH Device Record Key | 57793a1f-07ca-46ea-b4d9-1a5e3bf61006 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Harmony Polyisoprene Single Sleeve |
| Version Model Number | HA-101-INS |
| Catalog Number | REV C |
| Company DUNS | 208394130 |
| Company Name | Pamco Distributing Inc |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| 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 | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00628347062774 [Primary] |
| MSC | Barrier, Std, Oral Sex |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-06-07 |
| Device Publish Date | 2024-05-30 |
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| 00628347063870 - UltuCup Box Model 1 EN/FR/ES | 2024-08-26 |
| 00628347063894 - UltuCup Box Model 0 EN/FR/ES | 2024-08-22 |
| 00628347062736 - Harmony Latex Single Sleeve | 2024-06-07 |
| 00628347062774 - Harmony Polyisoprene Single Sleeve | 2024-06-07 |
| 00628347062774 - Harmony Polyisoprene Single Sleeve | 2024-06-07 |
| 00628347062729 - Harmony Latex Dam Bulk Box | 2024-04-02 Harmony Latex Dam Bulk Box 100/box |
| 00628347065881 - Harmony Polyisoprene Dam Retail Pack | 2024-04-02 Harmony Polyisoprene Dam Retail Pack 6/pack |
| 00628347069810 - Harmony Latex Dam Retail Pack | 2024-04-02 Harmony Latex Dam Retail Pack 6/pack |