OcciGuide ER GUIDE 1010
GUDID M710ERGUIDE10102
BIOTEX, INC.
Needle guide, single-use| Primary Device ID | M710ERGUIDE10102 |
| NIH Device Record Key | 8355a55c-cf72-4bc0-9e36-5272cc1626a7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OcciGuide |
| Version Model Number | 048-1000 |
| Catalog Number | ER GUIDE 1010 |
| Company DUNS | 969792050 |
| Company Name | BIOTEX, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | 7137410111 |
| xx@xx.xx | |
| Phone | 7137410111 |
| xx@xx.xx | |
| Phone | 7137410111 |
| xx@xx.xx | |
| Phone | 7137410111 |
| xx@xx.xx | |
| Phone | 7137410111 |
| xx@xx.xx | |
| Phone | 7137410111 |
| xx@xx.xx | |
| Phone | 7137410111 |
| xx@xx.xx | |
| Phone | 7137410111 |
| xx@xx.xx | |
| Phone | 7137410111 |
| xx@xx.xx | |
| Phone | 7137410111 |
| xx@xx.xx | |
| Phone | 7137410111 |
| xx@xx.xx | |
| Phone | 7137410111 |
| xx@xx.xx | |
| Phone | 7137410111 |
| xx@xx.xx | |
| Phone | 7137410111 |
| xx@xx.xx | |
| Phone | 7137410111 |
| xx@xx.xx | |
| Phone | 7137410111 |
| xx@xx.xx | |
| Phone | 7137410111 |
| xx@xx.xx | |
| Phone | 7137410111 |
| xx@xx.xx | |
| Phone | 7137410111 |
| xx@xx.xx | |
| Phone | 7137410111 |
| xx@xx.xx | |
| Phone | 7137410111 |
| xx@xx.xx | |
| Phone | 7137410111 |
| xx@xx.xx | |
| Phone | 7137410111 |
| xx@xx.xx | |
| Phone | 7137410111 |
| xx@xx.xx | |
| Phone | 7137410111 |
| xx@xx.xx | |
| Phone | 7137410111 |
| xx@xx.xx | |
| Phone | 7137410111 |
| xx@xx.xx | |
| Phone | 7137410111 |
| xx@xx.xx | |
| Phone | 7137410111 |
| xx@xx.xx |
Operating and Storage Conditions
| Handling Environment Temperature | Between -40 Degrees Celsius and 121 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 121 Degrees Celsius |
| Handling Environment Temperature | Between -40 Degrees Celsius and 121 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 121 Degrees Celsius |
| Handling Environment Temperature | Between -40 Degrees Celsius and 121 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 121 Degrees Celsius |
| Handling Environment Temperature | Between -40 Degrees Celsius and 121 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 121 Degrees Celsius |
| Handling Environment Temperature | Between -40 Degrees Celsius and 121 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 121 Degrees Celsius |
| Handling Environment Temperature | Between -40 Degrees Celsius and 121 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 121 Degrees Celsius |
| Handling Environment Temperature | Between -40 Degrees Celsius and 121 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 121 Degrees Celsius |
| Handling Environment Temperature | Between -40 Degrees Celsius and 121 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 121 Degrees Celsius |
| Handling Environment Temperature | Between -40 Degrees Celsius and 121 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 121 Degrees Celsius |
| Handling Environment Temperature | Between -40 Degrees Celsius and 121 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 121 Degrees Celsius |
| Handling Environment Temperature | Between -40 Degrees Celsius and 121 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 121 Degrees Celsius |
| Handling Environment Temperature | Between -40 Degrees Celsius and 121 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 121 Degrees Celsius |
| Handling Environment Temperature | Between -40 Degrees Celsius and 121 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 121 Degrees Celsius |
| Handling Environment Temperature | Between -40 Degrees Celsius and 121 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 121 Degrees Celsius |
| Handling Environment Temperature | Between -40 Degrees Celsius and 121 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 121 Degrees Celsius |
| Handling Environment Temperature | Between -40 Degrees Celsius and 121 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 121 Degrees Celsius |
| Handling Environment Temperature | Between -40 Degrees Celsius and 121 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 121 Degrees Celsius |
| Handling Environment Temperature | Between -40 Degrees Celsius and 121 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 121 Degrees Celsius |
| Handling Environment Temperature | Between -40 Degrees Celsius and 121 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 121 Degrees Celsius |
| Handling Environment Temperature | Between -40 Degrees Celsius and 121 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 121 Degrees Celsius |
| Handling Environment Temperature | Between -40 Degrees Celsius and 121 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 121 Degrees Celsius |
| Handling Environment Temperature | Between -40 Degrees Celsius and 121 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 121 Degrees Celsius |
| Handling Environment Temperature | Between -40 Degrees Celsius and 121 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 121 Degrees Celsius |
| Handling Environment Temperature | Between -40 Degrees Celsius and 121 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 121 Degrees Celsius |
| Handling Environment Temperature | Between -40 Degrees Celsius and 121 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 121 Degrees Celsius |
| Handling Environment Temperature | Between -40 Degrees Celsius and 121 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 121 Degrees Celsius |
| Handling Environment Temperature | Between -40 Degrees Celsius and 121 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 121 Degrees Celsius |
| Handling Environment Temperature | Between -40 Degrees Celsius and 121 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 121 Degrees Celsius |
| Handling Environment Temperature | Between -40 Degrees Celsius and 121 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 121 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M710ERGUIDE10100 [Primary] |
| HIBCC | M710ERGUIDE10102 [Package] Contains: M710ERGUIDE10100 Package: Shelf carton [10 Units] In Commercial Distribution |
FDA Product Code
| GDF | Guide, Needle, Surgical |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2022-06-17 |
| Device Publish Date | 2021-02-25 |
On-Brand Devices [OcciGuide]
| M710ERGUIDE1010 | ER GUIDE 1010 |
| M710ERGUIDE10052 | 048-1001 |
| M710ERGUIDE10102 | 048-1000 |
Trademark Results [OcciGuide]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OCCIGUIDE 87389281 5470957 Live/Registered |
Helios Medical Ventures LLC 2017-03-28 |
 OCCIGUIDE 87389266 5470956 Live/Registered |
Helios Medical Ventures LLC 2017-03-28 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.