Puragraft
GUDID 10848782033215
C-6 2-0 PTFE 18"/45CM
Surgical Specialties México, S. de R.L. de C.V.
Polyolefin suture, monofilament| Primary Device ID | 10848782033215 |
| NIH Device Record Key | c864fb0d-f56e-482a-b201-7265bbc33b6d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Puragraft |
| Version Model Number | PGT815B |
| Company DUNS | 812762226 |
| Company Name | Surgical Specialties México, S. de R.L. de C.V. |
| Device Count | 1 |
| DM Exempt | true |
| 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 |
Customer Support Contacts
Device Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
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| Device Size Text, specify | 0 |
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| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00848782033218 [Primary] |
| GS1 | 10848782033215 [Package] Contains: 00848782033218 Package: Box [12 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K160744
FDA Product Code
| NBY | SUTURE, SURGICAL, NONABSORBABLE, EXPANDED, POLYTETRAFLOUROETHYLENE |
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 | 2019-03-11 |
| Device Publish Date | 2019-02-18 |
On-Brand Devices [Puragraft]
| 10848782033277 | C-3 5-0 PTFE 18"/45CM |
| 10848782033260 | PC-31 4-0 PTFE 18"/45CM |
| 00848782033256 | C-3 4-0 PTFE 18"/45CM |
| 10848782033246 | C-22 3-0 PTFE 18"/45CM |
| 10848782033239 | C-22 4-0 PTFE 18"/45CM |
| 10848782033222 | C-6 3-0 PTFE 18"/45CM |
| 10848782033215 | C-6 2-0 PTFE 18"/45CM |
| 10848782033208 | C6 3-0 Bbs 18"/45cm |
| 10848782033192 | C6 4-0 Bbs 18"/45cm |
| 10848782033185 | C31 3-0 Pl Gut 18"/45cm |
| 10848782033178 | C6 4-0 Pl Gut 18"/45cm |
| 10848782033161 | C6 3-0 Ch Gut 27"/70cm |
| 10848782033154 | C6 4-0 Ch Gut 27"/70cm |
| 10848782033147 | C6 4-0 Ch Gut 18"/45cm |
| 10848782033130 | C6 3-0 Pl Gut 27"/70cm |
| 10848782033123 | C6 4-0 Pl Gut 27"/70cm |
| 00848782033119 | C6 3-0 Ch Gut 18"/45cm |
| 10848782033109 | C3 5-0 Ch Gut 18"/45cm |
Trademark Results [Puragraft]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PURAGRAFT 85192418 3989977 Live/Registered |
Puragraft LLC 2010-12-07 |
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