| Primary Device ID | 00853190008154 |
| NIH Device Record Key | d42437c7-ac99-4ecb-913a-26236285500c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TITAN™ DOUBLE WIRE |
| Version Model Number | 132.641.22 |
| Company DUNS | 063554875 |
| Company Name | JACE MEDICAL, LLC |
| Device Count | 2 |
| 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 | true |
| 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 | 00853190008154 [Package] Contains: 00853190008987 Package: Carton [12 Units] In Commercial Distribution |
| GS1 | 00853190008260 [Unit of Use] |
| GS1 | 00853190008987 [Primary] |
| GAO | Suture, Nonabsorbable |
| PTX | Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile, Exempt |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-10-18 |
| Device Publish Date | 2021-10-10 |
| 00853190008161 | MONOFILAMENT 316 LVM STAINLESS STEEL SUTURE, CCS1 NEEDLE, 49MM, 6 GA, 14", 3 PK |
| 00853190008154 | MONOFILAMENT 316 LVM STAINLESS STEEL SUTURE, CCS1 NEEDLE, 49MM, 6 GA, 14", 2 PK |
| 00853190008673 | MONOFILAMENT 316 LVM STAINLESS STEEL SUTURE, BE3 NEEDLE, 49MM, 6 GA, 14", 3 PK |
| 00853190008246 | MONOFILAMENT 316 LVM STAINLESS STEEL SUTURE, BE3 NEEDLE, 49MM, 6 GA, 14", 2 PK |
| 00853190008659 | MONOFILAMENT 316 LVM STAINLESS STEEL SUTURE, BE2 NEEDLE, 65MM, 6 GA, 14", 3 PK |
| 00853190008147 | MONOFILAMENT 316 LVM STAINLESS STEEL SUTURE, BE2 NEEDLE, 65MM, 6 GA, 14", 2 PK |
| 00853190008192 | MONOFILAMENT 316 LVM STAINLESS STEEL SUTURE, CCS2 NEEDLE, 59MM, 8 GA, 14", 2 PK |
| 00853190008697 | MONOFILAMENT 316 LVM STAINLESS STEEL SUTURE, CCS2 NEEDLE, 59MM, 6 GA, 14", 3 PK |
| 00853190008178 | MONOFILAMENT 316 LVM STAINLESS STEEL SUTURE, CCS2 NEEDLE, 59MM, 6 GA, 14", 2 PK |
| 00853190008185 | MONOFILAMENT 316 LVM STAINLESS STEEL SUTURE, CCS1 NEEDLE, 49MM, 6 GA, 18", 2 PK |
| 00853190008123 | MONOFILAMENT 316 LVM STAINLESS STEEL SUTURE, MC2 NEEDLE, 59MM, 6 GA, 14", 2 PK |
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