Primary Device ID | 10848782041999 |
NIH Device Record Key | 48e17502-fccc-4b0f-b071-58c6fa9258b1 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | DYNEK |
Version Model Number | GDK8H805 |
Catalog Number | GDK8H805 |
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 |
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Device Size Text, specify | 0 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00848782041992 [Primary] |
GS1 | 10848782041999 [Package] Contains: 00848782041992 Package: Box [12 Units] In Commercial Distribution |
GAW | Suture, nonabsorbable, synthetic, polypropylene |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2021-11-01 |
Device Publish Date | 2021-10-22 |
10848782042743 | 2xHDS-18-680 P USP 2-0 Polyester green76 cm. pledgets 3x6. sterile VA6.1 |
10848782042040 | VDS-16.0-200 USP 10-0 Polypropylene blue (loop) 10 cm. sterile VA1.4 |
10848782042033 | 2xVLZ-8.0-350 USP 5-0 Polyester white 45 cm. sterile VA6.1 |
10848782042026 | 2xDLZ-8.0-300 USP 5-0 Polyester white 45 cm. sterile VA6.1 |
10848782042019 | 2xDLZ-6.0-150 USP 8-0 Silk blue 30 cm. sterile VA1.4 |
10848782042002 | 2xVLZ-8.0-350 USP 5-0 Polyester green 45 cm. sterile VA6.1 |
10848782041999 | 2xDRS-8.0-230 USP 8-0 Polypropylene blue 75 cm. sterile VA8.1 |
10848782041982 | 2xDRS-8.0-230 USP 7-0 Polypropylene blue 75 cm. sterile VA9.1 |
10848782041975 | 2xDRS-8.0-230 USP 7-0 Polypropylene blue 60 cm. sterile VA9.1 |