AceConnex™ PSF141140-6
GUDID 00810053078709
AceConnex™ Pre-Sutured Fascia
ALLOSOURCE
Cadaveric-donor fascia allograft| Primary Device ID | 00810053078709 |
| NIH Device Record Key | 73b2598c-a6c8-403a-b2ad-673a3ca3a428 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AceConnex™ |
| Version Model Number | PSF141140-6 |
| Catalog Number | PSF141140-6 |
| Company DUNS | 946808136 |
| Company Name | ALLOSOURCE |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | true |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | true |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Device Dimensions
| Length | 140 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 140 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 140 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 140 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 140 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 140 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 140 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 140 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 140 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 140 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 140 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 140 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 140 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 140 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 140 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 140 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 140 Millimeter |
| Outer Diameter | 5.5 Millimeter |
Operating and Storage Conditions
| Storage Environment Temperature | Between 0 Degrees Celsius and -40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -40 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810053078709 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K213046
FDA Product Code
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-11-16 |
| Device Publish Date | 2023-11-08 |
On-Brand Devices [AceConnex™]
| 00810053078709 | AceConnex™ Pre-Sutured Fascia |
| 00810053078693 | AceConnex™ Pre-Sutured Fascia |
| 00810053078686 | AceConnex™ Pre-Sutured Fascia |
| 00810053078679 | AceConne™ Pre-Sutured Fascia |
| 00810053078662 | AceConnex™ Pre-Sutured Fascia |
| 00810053078655 | AceConnex™ Pre-Sutured Fascia |
Trademark Results [AceConnex]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ACECONNEX 90234928 not registered Live/Pending |
Allosource 2020-10-05 |
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