| Primary Device ID | 00816287020170 |
| NIH Device Record Key | e1b604f6-8bc2-42b1-b299-2d19f8a8b94e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | iovera Smart Tip |
| Version Model Number | STT0801-5 |
| Company DUNS | 799347229 |
| Company Name | PACIRA CRYOTECH, INC. |
| Device Count | 5 |
| 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 | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00816287020170 [Unit of Use] |
| GS1 | 00816287020187 [Primary] |
| GXH | Device, Surgical, Cryogenic |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00816287020170]
Ethylene Oxide
[00816287020170]
Ethylene Oxide
[00816287020170]
Ethylene Oxide
[00816287020170]
Ethylene Oxide
[00816287020170]
Ethylene Oxide
[00816287020170]
Ethylene Oxide
[00816287020170]
Ethylene Oxide
[00816287020170]
Ethylene Oxide
[00816287020170]
Ethylene Oxide
[00816287020170]
Ethylene Oxide
[00816287020170]
Ethylene Oxide
[00816287020170]
Ethylene Oxide
[00816287020170]
Ethylene Oxide
[00816287020170]
Ethylene Oxide
[00816287020170]
Ethylene Oxide
[00816287020170]
Ethylene Oxide
[00816287020170]
Ethylene Oxide
[00816287020170]
Ethylene Oxide
[00816287020170]
Ethylene Oxide
[00816287020170]
Ethylene Oxide
[00816287020170]
Ethylene Oxide
[00816287020170]
Ethylene Oxide
[00816287020170]
Ethylene Oxide
[00816287020170]
Ethylene Oxide
[00816287020170]
Ethylene Oxide
[00816287020170]
Ethylene Oxide
[00816287020170]
Ethylene Oxide
[00816287020170]
Ethylene Oxide
[00816287020170]
Ethylene Oxide
[00816287020170]
Ethylene Oxide
[00816287020170]
Ethylene Oxide
[00816287020170]
Ethylene Oxide
[00816287020170]
Ethylene Oxide
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Ethylene Oxide
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-06-23 |
| Device Publish Date | 2023-06-15 |
| 00816287020279 | SMART TIP, STIMULATING (1X90MM), 5-PACK |
| 00816287020224 | SMART TIP (3X8.5MM), 5-PACK |
| 00816287020200 | SMART TIP (1X90MM), 5-PACK |
| 00816287020170 | SMART TIP (1X90MM), 5-PACK |
| 00816287020132 | SMART TIP (3X8.5MM), 5-PACK |
| 00816287020101 | SMART TIP, STIMULATING (1X90MM), 5-PACK |