Surguard®3 SG3-2138RB
GUDID 35413206222460
Surguard®3 Safety Hypodermic Needle
Terumo Europe NV
Hypodermic needle, single-use| Primary Device ID | 35413206222460 |
| NIH Device Record Key | 84570694-b07b-4eb4-9bc2-846bd67e0d31 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Surguard®3 |
| Version Model Number | SG3-2138RB |
| Catalog Number | SG3-2138RB |
| Company DUNS | 370193559 |
| Company Name | Terumo Europe NV |
| Device Count | 1 |
| 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 | 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
| Needle Gauge | 21 Gauge |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Needle Gauge | 21 Gauge |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Needle Gauge | 21 Gauge |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Needle Gauge | 21 Gauge |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Needle Gauge | 21 Gauge |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Needle Gauge | 21 Gauge |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Needle Gauge | 21 Gauge |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Needle Gauge | 21 Gauge |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Needle Gauge | 21 Gauge |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Needle Gauge | 21 Gauge |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Needle Gauge | 21 Gauge |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Needle Gauge | 21 Gauge |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Needle Gauge | 21 Gauge |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Needle Gauge | 21 Gauge |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Needle Gauge | 21 Gauge |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Needle Gauge | 21 Gauge |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Needle Gauge | 21 Gauge |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Needle Gauge | 21 Gauge |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Do not store at extreme temperature and humidity. Keep away from sunlight. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store at extreme temperature and humidity. Keep away from sunlight. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store at extreme temperature and humidity. Keep away from sunlight. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store at extreme temperature and humidity. Keep away from sunlight. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store at extreme temperature and humidity. Keep away from sunlight. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store at extreme temperature and humidity. Keep away from sunlight. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store at extreme temperature and humidity. Keep away from sunlight. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store at extreme temperature and humidity. Keep away from sunlight. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store at extreme temperature and humidity. Keep away from sunlight. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store at extreme temperature and humidity. Keep away from sunlight. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store at extreme temperature and humidity. Keep away from sunlight. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store at extreme temperature and humidity. Keep away from sunlight. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store at extreme temperature and humidity. Keep away from sunlight. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store at extreme temperature and humidity. Keep away from sunlight. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store at extreme temperature and humidity. Keep away from sunlight. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store at extreme temperature and humidity. Keep away from sunlight. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store at extreme temperature and humidity. Keep away from sunlight. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store at extreme temperature and humidity. Keep away from sunlight. Keep dry. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05413206222469 [Primary] |
| GS1 | 35413206222460 [Package] Contains: 05413206222469 Package: Tray [280 Units] In Commercial Distribution |
| GS1 | 55413206222464 [Package] Package: Carton [4 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K212095
FDA Product Code
| FMI | Needle, Hypodermic, Single Lumen |
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 | 2022-11-07 |
| Device Publish Date | 2022-10-28 |
On-Brand Devices [Surguard®3]
| 35413206222477 | Surguard®3 Safety Hypodermic Needle |
| 35413206222460 | Surguard®3 Safety Hypodermic Needle |
| 35413206222453 | Surguard®3 Safety Hypodermic Needle |
| 35413206222446 | Surguard®3 Safety Hypodermic Needle |
Trademark Results [Surguard]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SURGUARD 76209248 2641927 Live/Registered |
Terumo Medical Corporation 2001-02-14 |
 SURGUARD 76205608 2802858 Live/Registered |
Terumo Medical Corporation 2001-02-06 |
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