| Primary Device ID | 10848782009098 |
| NIH Device Record Key | dab89fb7-4004-4820-9f69-2895436d9660 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | C16 5-0 Ch Gut 18"/45cm |
| Version Model Number | 543B |
| Catalog Number | 543 |
| 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 |
| 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 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 00848782009091 [Primary] |
| GS1 | 10848782009098 [Package] Contains: 00848782009091 Package: Box [12 Units] In Commercial Distribution |
| GAL | SUTURE, ABSORBABLE, NATURAL |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2015-10-20 |
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| 20705031227986 - Stratafix Spiral | 2023-12-25 PS-2 3-0 MONODERM 30CM |
| 20705031227993 - Stratafix Spiral | 2023-12-25 CT-1 0 MONODERM 45CM |
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| 20705031228013 - Stratafix Spiral | 2023-12-25 PS-2 2-0 MONODERM 30CM |
| 20705031228020 - Stratafix Spiral | 2023-12-25 CT-1 1 MONODERM 45CM |
| 20705031228037 - Stratafix Spiral | 2023-12-25 SH 0 MONODERM 20CM |
| 20705031228044 - Stratafix Spiral | 2023-12-25 PS-1 2-0 MONODERM 30CM |