Biotronix Healthcare GE36416
GUDID 20858835007039
Disposable Hypodermic Needle 21G x 1 1/2
BIOTRONIX HEALTHCARE INDUSTRIES, INC.
Hypodermic needle, single-use| Primary Device ID | 20858835007039 |
| NIH Device Record Key | e77ceeb4-523e-4d88-aee2-b4b04229a2e9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Biotronix Healthcare |
| Version Model Number | GE36416 |
| Catalog Number | GE36416 |
| Company DUNS | 065762392 |
| Company Name | BIOTRONIX HEALTHCARE INDUSTRIES, 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 | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Dimensions
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00858835007035 [Primary] |
| GS1 | 10858835007032 [Package] Contains: 00858835007035 Package: Inner Box [100 Units] In Commercial Distribution |
| GS1 | 20858835007039 [Package] Contains: 10858835007032 Package: Case [100 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K050999
FDA Product Code
| FMI | Needle, Hypodermic, Single Lumen |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-12-24 |
| Device Publish Date | 2019-10-06 |
On-Brand Devices [Biotronix Healthcare]
| 20858835007053 | Disposable Hypodermic Needles 23G x 1" |
| 20858835007046 | Disposable Hypodermic Needles 22G x 1 1/2" |
| 20858835007039 | Disposable Hypodermic Needle 21G x 1 1/2 |
| 20858835007022 | Disposable Hypodermic Needle 20G x 1 1/2" |
| 20858835007015 | Disposable Hypodermic Needle 18G x 1 1/2" |
| 20858835007008 | Disposable Hypodermic Needles 18G x 1" |
| 10850005165283 | Enteral Delivery Gravity Bag Set w/ ENFit™* Connector |
| 10850005165276 | Enteral Delivery Pump Bag Set w/ ENFit™* Connector |
| 10850005165108 | Nebulizer with Pediatric Elongated Mask, 7ft. No Crush Tubing and Standard Connector |
| 10850005165092 | Nebulizer with Adult Mask, 7ft. No Crush Tubing and Standard Connector |
| 10850005165078 | Nebulizer with Elongated Adult Mask, 7ft. No Crush Tubing and Universal Connector |
| 10850005165054 | Minor Laceration Tray w/ Instrument |
| 10850005165047 | Irrigation Tray with Piston Syringe |
| 10850005165030 | Irrigation Tray with Bulb Syringe |
Trademark Results [Biotronix Healthcare]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BIOTRONIX HEALTHCARE 86094840 4616297 Live/Registered |
Biotronix Healthcare Industries Inc. 2013-10-18 |
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