ST-9 8002
GUDID B68280021
Allergy Testing Lancet
MEDSCIENCE RESEARCH GROUP, INC.
Allergy testing lancet| Primary Device ID | B68280021 |
| NIH Device Record Key | 95206e99-1d32-40aa-b943-47f49b082b68 |
| Commercial Distribution Discontinuation | 2025-10-30 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ST-9 |
| Version Model Number | 8002 |
| Catalog Number | 8002 |
| Company DUNS | 013114656 |
| Company Name | MEDSCIENCE RESEARCH GROUP, INC. |
| 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
| Phone | 561-499-0411 |
| marvin.smollar@medscienceinc.com | |
| Phone | 561-499-0411 |
| marvin.smollar@medscienceinc.com | |
| Phone | 561-499-0411 |
| marvin.smollar@medscienceinc.com | |
| Phone | 561-499-0411 |
| marvin.smollar@medscienceinc.com | |
| Phone | 561-499-0411 |
| marvin.smollar@medscienceinc.com | |
| Phone | 561-499-0411 |
| marvin.smollar@medscienceinc.com | |
| Phone | 561-499-0411 |
| marvin.smollar@medscienceinc.com | |
| Phone | 561-499-0411 |
| marvin.smollar@medscienceinc.com | |
| Phone | 561-499-0411 |
| marvin.smollar@medscienceinc.com | |
| Phone | 561-499-0411 |
| marvin.smollar@medscienceinc.com | |
| Phone | 561-499-0411 |
| marvin.smollar@medscienceinc.com | |
| Phone | 561-499-0411 |
| marvin.smollar@medscienceinc.com | |
| Phone | 561-499-0411 |
| marvin.smollar@medscienceinc.com | |
| Phone | 561-499-0411 |
| marvin.smollar@medscienceinc.com | |
| Phone | 561-499-0411 |
| marvin.smollar@medscienceinc.com | |
| Phone | 561-499-0411 |
| marvin.smollar@medscienceinc.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B68280021 [Primary] |
| HIBCC | B682800217202103 [Package] Package: Bag [36 Units] Discontinued: 2025-10-30 In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K172062
FDA Product Code
| LDH | System, Delivery, Allergen And Vaccine |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[B68280021]
Ethylene Oxide
[B68280021]
Ethylene Oxide
[B68280021]
Ethylene Oxide
[B68280021]
Ethylene Oxide
[B68280021]
Ethylene Oxide
[B68280021]
Ethylene Oxide
[B68280021]
Ethylene Oxide
[B68280021]
Ethylene Oxide
[B68280021]
Ethylene Oxide
[B68280021]
Ethylene Oxide
[B68280021]
Ethylene Oxide
[B68280021]
Ethylene Oxide
[B68280021]
Ethylene Oxide
[B68280021]
Ethylene Oxide
[B68280021]
Ethylene Oxide
[B68280021]
Ethylene Oxide
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-10-08 |
| Device Publish Date | 2021-09-30 |
On-Brand Devices [ST-9]
| B68280021 | Allergy Testing Lancet |
| B6828002 | 36 Single head applicators packed as 4 sets of 9 single head applicators per set |
| B682100012 | Asymmetric Multiple Skin Testing Device for Percutaneous Skin Testing, 12 applicators individual |
Trademark Results [ST-9]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ST-9 88580390 not registered Live/Pending |
ST-9, Inc. 2019-08-15 |
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