SYNA MEDICAL SYNAG150XL
GUDID 30197344098198
GLOVE, EXAM, VINYL, SYNA, PF, XL
MEDLINE INDUSTRIES, INC.
Vinyl examination/treatment glove, non-powdered| Primary Device ID | 30197344098198 |
| NIH Device Record Key | 7c43f4e0-00c5-4e76-a878-7599423dd557 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SYNA MEDICAL |
| Version Model Number | SYNAG150XL |
| Catalog Number | SYNAG150XL |
| Company DUNS | 025460908 |
| Company Name | MEDLINE INDUSTRIES, INC. |
| Device Count | 130 |
| DM Exempt | false |
| 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 | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(800)633-5463 |
| service@medline.com | |
| Phone | +1(800)633-5463 |
| service@medline.com | |
| Phone | +1(800)633-5463 |
| service@medline.com | |
| Phone | +1(800)633-5463 |
| service@medline.com | |
| Phone | +1(800)633-5463 |
| service@medline.com | |
| Phone | +1(800)633-5463 |
| service@medline.com | |
| Phone | +1(800)633-5463 |
| service@medline.com | |
| Phone | +1(800)633-5463 |
| service@medline.com | |
| Phone | +1(800)633-5463 |
| service@medline.com | |
| Phone | +1(800)633-5463 |
| service@medline.com | |
| Phone | +1(800)633-5463 |
| service@medline.com | |
| Phone | +1(800)633-5463 |
| service@medline.com | |
| Phone | +1(800)633-5463 |
| service@medline.com | |
| Phone | +1(800)633-5463 |
| service@medline.com | |
| Phone | +1(800)633-5463 |
| service@medline.com | |
| Phone | +1(800)633-5463 |
| service@medline.com |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Protect from freezing, avoid excessive heat. Keep dry. Shield from direct sunlight, fluorescent lighting, x-rays, moisture and ozone. |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from freezing, avoid excessive heat. Keep dry. Shield from direct sunlight, fluorescent lighting, x-rays, moisture and ozone. |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from freezing, avoid excessive heat. Keep dry. Shield from direct sunlight, fluorescent lighting, x-rays, moisture and ozone. |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from freezing, avoid excessive heat. Keep dry. Shield from direct sunlight, fluorescent lighting, x-rays, moisture and ozone. |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from freezing, avoid excessive heat. Keep dry. Shield from direct sunlight, fluorescent lighting, x-rays, moisture and ozone. |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from freezing, avoid excessive heat. Keep dry. Shield from direct sunlight, fluorescent lighting, x-rays, moisture and ozone. |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from freezing, avoid excessive heat. Keep dry. Shield from direct sunlight, fluorescent lighting, x-rays, moisture and ozone. |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from freezing, avoid excessive heat. Keep dry. Shield from direct sunlight, fluorescent lighting, x-rays, moisture and ozone. |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from freezing, avoid excessive heat. Keep dry. Shield from direct sunlight, fluorescent lighting, x-rays, moisture and ozone. |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from freezing, avoid excessive heat. Keep dry. Shield from direct sunlight, fluorescent lighting, x-rays, moisture and ozone. |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from freezing, avoid excessive heat. Keep dry. Shield from direct sunlight, fluorescent lighting, x-rays, moisture and ozone. |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from freezing, avoid excessive heat. Keep dry. Shield from direct sunlight, fluorescent lighting, x-rays, moisture and ozone. |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from freezing, avoid excessive heat. Keep dry. Shield from direct sunlight, fluorescent lighting, x-rays, moisture and ozone. |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from freezing, avoid excessive heat. Keep dry. Shield from direct sunlight, fluorescent lighting, x-rays, moisture and ozone. |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from freezing, avoid excessive heat. Keep dry. Shield from direct sunlight, fluorescent lighting, x-rays, moisture and ozone. |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from freezing, avoid excessive heat. Keep dry. Shield from direct sunlight, fluorescent lighting, x-rays, moisture and ozone. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10197344098194 [Unit of Use] |
| GS1 | 20197344098191 [Primary] |
| GS1 | 30197344098198 [Package] Contains: 20197344098191 Package: CS [10 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K131832
FDA Product Code
| LYZ | Vinyl patient examination glove |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-10-04 |
| Device Publish Date | 2024-09-26 |
On-Brand Devices [SYNA MEDICAL]
| 30197344098235 | GLOVE, EXAM, NITRILE, SYNA, PF, XL |
| 30197344098228 | GLOVE, EXAM, NITRILE, SYNA, PF, S |
| 30197344098211 | GLOVE, EXAM, NITRILE, SYNA, PF, M |
| 30197344098204 | GLOVE, EXAM, NITRILE, SYNA, PF, L |
| 30197344098198 | GLOVE, EXAM, VINYL, SYNA, PF, XL |
| 30197344098174 | GLOVE, EXAM, VINYL, SYNA, PF, M |
| 30197344098167 | GLOVE, EXAM, VINYL, SYNA, PF, L |
| 30197344098181 | GLOVE, EXAM, VINYL, SYNA, PF, S |
Trademark Results [SYNA MEDICAL]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SYNA MEDICAL 97088156 not registered Live/Pending |
Syna Medical, LLC 2021-10-22 |
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