| Primary Device ID | 00890594000933 |
| NIH Device Record Key | b8c42e34-9fb8-40ed-a8bc-d8fe0a7f1081 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Transobturator Inside-Out, Right 3.2 mm Introducer |
| Version Model Number | CAL-IOR32 |
| Catalog Number | CAL-IOR32 |
| Company DUNS | 130341956 |
| Company Name | CALDERA MEDICAL, INC. |
| Device Count | 1 |
| DM Exempt | true |
| 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 1-866-422-5337 |
| info@calderamedical.com | |
| Phone | 1-866-422-5337 |
| info@calderamedical.com | |
| Phone | 1-866-422-5337 |
| info@calderamedical.com | |
| Phone | 1-866-422-5337 |
| info@calderamedical.com | |
| Phone | 1-866-422-5337 |
| info@calderamedical.com | |
| Phone | 1-866-422-5337 |
| info@calderamedical.com | |
| Phone | 1-866-422-5337 |
| info@calderamedical.com | |
| Phone | 1-866-422-5337 |
| info@calderamedical.com | |
| Phone | 1-866-422-5337 |
| info@calderamedical.com | |
| Phone | 1-866-422-5337 |
| info@calderamedical.com | |
| Phone | 1-866-422-5337 |
| info@calderamedical.com | |
| Phone | 1-866-422-5337 |
| info@calderamedical.com | |
| Phone | 1-866-422-5337 |
| info@calderamedical.com | |
| Phone | 1-866-422-5337 |
| info@calderamedical.com | |
| Phone | 1-866-422-5337 |
| info@calderamedical.com | |
| Phone | 1-866-422-5337 |
| info@calderamedical.com | |
| Phone | 1-866-422-5337 |
| info@calderamedical.com | |
| Phone | 1-866-422-5337 |
| info@calderamedical.com | |
| Phone | 1-866-422-5337 |
| info@calderamedical.com | |
| Phone | 1-818-879-6555 |
| hello@calderamedical.com | |
| Phone | 1-818-879-6555 |
| hello@calderamedical.com | |
| Phone | 1-818-879-6555 |
| hello@calderamedical.com | |
| Phone | 1-818-879-6555 |
| hello@calderamedical.com | |
| Phone | 1-818-879-6555 |
| hello@calderamedical.com | |
| Phone | 1-818-879-6555 |
| hello@calderamedical.com | |
| Phone | 1-818-879-6555 |
| hello@calderamedical.com | |
| Phone | 1-818-879-6555 |
| hello@calderamedical.com | |
| Phone | 1-818-879-6555 |
| hello@calderamedical.com | |
| Phone | 1-818-879-6555 |
| hello@calderamedical.com | |
| Phone | 1-818-879-6555 |
| hello@calderamedical.com | |
| Phone | 1-818-879-6555 |
| hello@calderamedical.com | |
| Phone | 1-818-879-6555 |
| hello@calderamedical.com | |
| Phone | 1-818-879-6555 |
| hello@calderamedical.com | |
| Phone | 1-818-879-6555 |
| hello@calderamedical.com | |
| Phone | 1-818-879-6555 |
| hello@calderamedical.com | |
| Phone | 1-818-879-6555 |
| hello@calderamedical.com | |
| Phone | 1-818-879-6555 |
| hello@calderamedical.com | |
| Phone | 1-818-879-6555 |
| hello@calderamedical.com | |
| Phone | 1-818-879-6555 |
| hello@calderamedical.com | |
| Phone | 1-818-879-6555 |
| hello@calderamedical.com | |
| Phone | 1-818-879-6555 |
| hello@calderamedical.com | |
| Phone | 1-818-879-6555 |
| hello@calderamedical.com | |
| Phone | 1-818-879-6555 |
| hello@calderamedical.com | |
| Phone | 1-818-879-6555 |
| hello@calderamedical.com | |
| Phone | 1-818-879-6555 |
| hello@calderamedical.com | |
| Phone | 1-818-879-6555 |
| hello@calderamedical.com | |
| Phone | 1-818-879-6555 |
| hello@calderamedical.com | |
| Phone | 1-818-879-6555 |
| hello@calderamedical.com | |
| Phone | 1-818-879-6555 |
| hello@calderamedical.com | |
| Phone | 1-818-879-6555 |
| hello@calderamedical.com | |
| Phone | 1-818-879-6555 |
| hello@calderamedical.com | |
| Phone | 1-818-879-6555 |
| hello@calderamedical.com | |
| Phone | 1-818-879-6555 |
| hello@calderamedical.com | |
| Phone | 1-818-879-6555 |
| hello@calderamedical.com | |
| Phone | 1-818-879-6555 |
| hello@calderamedical.com | |
| Phone | 1-818-879-6555 |
| hello@calderamedical.com | |
| Phone | 1-818-879-6555 |
| hello@calderamedical.com | |
| Phone | 1-818-879-6555 |
| hello@calderamedical.com |
| Special Storage Condition, Specify | Between 0 and 0 *Store wrapped instruments in a designated sterile supply area that protects sterile items and their packaging from damage. This area should be clean, dry and free of contaminants. |
| Special Storage Condition, Specify | Between 0 and 0 *Store wrapped instruments in a designated sterile supply area that protects sterile items and their packaging from damage. This area should be clean, dry and free of contaminants. |
| Special Storage Condition, Specify | Between 0 and 0 *Store wrapped instruments in a designated sterile supply area that protects sterile items and their packaging from damage. This area should be clean, dry and free of contaminants. |
| Special Storage Condition, Specify | Between 0 and 0 *Store wrapped instruments in a designated sterile supply area that protects sterile items and their packaging from damage. This area should be clean, dry and free of contaminants. |
| Special Storage Condition, Specify | Between 0 and 0 *Store wrapped instruments in a designated sterile supply area that protects sterile items and their packaging from damage. This area should be clean, dry and free of contaminants. |
| Special Storage Condition, Specify | Between 0 and 0 *Store wrapped instruments in a designated sterile supply area that protects sterile items and their packaging from damage. This area should be clean, dry and free of contaminants. |
| Special Storage Condition, Specify | Between 0 and 0 *Store wrapped instruments in a designated sterile supply area that protects sterile items and their packaging from damage. This area should be clean, dry and free of contaminants. |
| Special Storage Condition, Specify | Between 0 and 0 *Store wrapped instruments in a designated sterile supply area that protects sterile items and their packaging from damage. This area should be clean, dry and free of contaminants. |
| Special Storage Condition, Specify | Between 0 and 0 *Store wrapped instruments in a designated sterile supply area that protects sterile items and their packaging from damage. This area should be clean, dry and free of contaminants. |
| Special Storage Condition, Specify | Between 0 and 0 *Store wrapped instruments in a designated sterile supply area that protects sterile items and their packaging from damage. This area should be clean, dry and free of contaminants. |
| Special Storage Condition, Specify | Between 0 and 0 *Store wrapped instruments in a designated sterile supply area that protects sterile items and their packaging from damage. This area should be clean, dry and free of contaminants. |
| Special Storage Condition, Specify | Between 0 and 0 *Store wrapped instruments in a designated sterile supply area that protects sterile items and their packaging from damage. This area should be clean, dry and free of contaminants. |
| Special Storage Condition, Specify | Between 0 and 0 *Store wrapped instruments in a designated sterile supply area that protects sterile items and their packaging from damage. This area should be clean, dry and free of contaminants. |
| Special Storage Condition, Specify | Between 0 and 0 *Store wrapped instruments in a designated sterile supply area that protects sterile items and their packaging from damage. This area should be clean, dry and free of contaminants. |
| Special Storage Condition, Specify | Between 0 and 0 *Store wrapped instruments in a designated sterile supply area that protects sterile items and their packaging from damage. This area should be clean, dry and free of contaminants. |
| Special Storage Condition, Specify | Between 0 and 0 *Store wrapped instruments in a designated sterile supply area that protects sterile items and their packaging from damage. This area should be clean, dry and free of contaminants. |
| Special Storage Condition, Specify | Between 0 and 0 *Store wrapped instruments in a designated sterile supply area that protects sterile items and their packaging from damage. This area should be clean, dry and free of contaminants. |
| Special Storage Condition, Specify | Between 0 and 0 *Store wrapped instruments in a designated sterile supply area that protects sterile items and their packaging from damage. This area should be clean, dry and free of contaminants. |
| Special Storage Condition, Specify | Between 0 and 0 *Store wrapped instruments in a designated sterile supply area that protects sterile items and their packaging from damage. This area should be clean, dry and free of contaminants. |
| Special Storage Condition, Specify | Between 0 and 0 *Store wrapped instruments in a designated sterile supply area that protects sterile items and their packaging from damage. This area should be clean, dry and free of contaminants. |
| Special Storage Condition, Specify | Between 0 and 0 *Store wrapped instruments in a designated sterile supply area that protects sterile items and their packaging from damage. This area should be clean, dry and free of contaminants. |
| Special Storage Condition, Specify | Between 0 and 0 *Store wrapped instruments in a designated sterile supply area that protects sterile items and their packaging from damage. This area should be clean, dry and free of contaminants. |
| Special Storage Condition, Specify | Between 0 and 0 *Store wrapped instruments in a designated sterile supply area that protects sterile items and their packaging from damage. This area should be clean, dry and free of contaminants. |
| Special Storage Condition, Specify | Between 0 and 0 *Store wrapped instruments in a designated sterile supply area that protects sterile items and their packaging from damage. This area should be clean, dry and free of contaminants. |
| Special Storage Condition, Specify | Between 0 and 0 *Store wrapped instruments in a designated sterile supply area that protects sterile items and their packaging from damage. This area should be clean, dry and free of contaminants. |
| Special Storage Condition, Specify | Between 0 and 0 *Store wrapped instruments in a designated sterile supply area that protects sterile items and their packaging from damage. This area should be clean, dry and free of contaminants. |
| Special Storage Condition, Specify | Between 0 and 0 *Store wrapped instruments in a designated sterile supply area that protects sterile items and their packaging from damage. This area should be clean, dry and free of contaminants. |
| Special Storage Condition, Specify | Between 0 and 0 *Store wrapped instruments in a designated sterile supply area that protects sterile items and their packaging from damage. This area should be clean, dry and free of contaminants. |
| Special Storage Condition, Specify | Between 0 and 0 *Store wrapped instruments in a designated sterile supply area that protects sterile items and their packaging from damage. This area should be clean, dry and free of contaminants. |
| Special Storage Condition, Specify | Between 0 and 0 *Store wrapped instruments in a designated sterile supply area that protects sterile items and their packaging from damage. This area should be clean, dry and free of contaminants. |
| Special Storage Condition, Specify | Between 0 and 0 *Store wrapped instruments in a designated sterile supply area that protects sterile items and their packaging from damage. This area should be clean, dry and free of contaminants. |
| Special Storage Condition, Specify | Between 0 and 0 *Store wrapped instruments in a designated sterile supply area that protects sterile items and their packaging from damage. This area should be clean, dry and free of contaminants. |
| Special Storage Condition, Specify | Between 0 and 0 *Store wrapped instruments in a designated sterile supply area that protects sterile items and their packaging from damage. This area should be clean, dry and free of contaminants. |
| Special Storage Condition, Specify | Between 0 and 0 *Store wrapped instruments in a designated sterile supply area that protects sterile items and their packaging from damage. This area should be clean, dry and free of contaminants. |
| Special Storage Condition, Specify | Between 0 and 0 *Store wrapped instruments in a designated sterile supply area that protects sterile items and their packaging from damage. This area should be clean, dry and free of contaminants. |
| Special Storage Condition, Specify | Between 0 and 0 *Store wrapped instruments in a designated sterile supply area that protects sterile items and their packaging from damage. This area should be clean, dry and free of contaminants. |
| Special Storage Condition, Specify | Between 0 and 0 *Store wrapped instruments in a designated sterile supply area that protects sterile items and their packaging from damage. This area should be clean, dry and free of contaminants. |
| Special Storage Condition, Specify | Between 0 and 0 *Store wrapped instruments in a designated sterile supply area that protects sterile items and their packaging from damage. This area should be clean, dry and free of contaminants. |
| Special Storage Condition, Specify | Between 0 and 0 *Store wrapped instruments in a designated sterile supply area that protects sterile items and their packaging from damage. This area should be clean, dry and free of contaminants. |
| Special Storage Condition, Specify | Between 0 and 0 *Store wrapped instruments in a designated sterile supply area that protects sterile items and their packaging from damage. This area should be clean, dry and free of contaminants. |
| Special Storage Condition, Specify | Between 0 and 0 *Store wrapped instruments in a designated sterile supply area that protects sterile items and their packaging from damage. This area should be clean, dry and free of contaminants. |
| Special Storage Condition, Specify | Between 0 and 0 *Store wrapped instruments in a designated sterile supply area that protects sterile items and their packaging from damage. This area should be clean, dry and free of contaminants. |
| Special Storage Condition, Specify | Between 0 and 0 *Store wrapped instruments in a designated sterile supply area that protects sterile items and their packaging from damage. This area should be clean, dry and free of contaminants. |
| Special Storage Condition, Specify | Between 0 and 0 *Store wrapped instruments in a designated sterile supply area that protects sterile items and their packaging from damage. This area should be clean, dry and free of contaminants. |
| Special Storage Condition, Specify | Between 0 and 0 *Store wrapped instruments in a designated sterile supply area that protects sterile items and their packaging from damage. This area should be clean, dry and free of contaminants. |
| Special Storage Condition, Specify | Between 0 and 0 *Store wrapped instruments in a designated sterile supply area that protects sterile items and their packaging from damage. This area should be clean, dry and free of contaminants. |
| Special Storage Condition, Specify | Between 0 and 0 *Store wrapped instruments in a designated sterile supply area that protects sterile items and their packaging from damage. This area should be clean, dry and free of contaminants. |
| Special Storage Condition, Specify | Between 0 and 0 *Store wrapped instruments in a designated sterile supply area that protects sterile items and their packaging from damage. This area should be clean, dry and free of contaminants. |
| Special Storage Condition, Specify | Between 0 and 0 *Store wrapped instruments in a designated sterile supply area that protects sterile items and their packaging from damage. This area should be clean, dry and free of contaminants. |
| Special Storage Condition, Specify | Between 0 and 0 *Store wrapped instruments in a designated sterile supply area that protects sterile items and their packaging from damage. This area should be clean, dry and free of contaminants. |
| Special Storage Condition, Specify | Between 0 and 0 *Store wrapped instruments in a designated sterile supply area that protects sterile items and their packaging from damage. This area should be clean, dry and free of contaminants. |
| Special Storage Condition, Specify | Between 0 and 0 *Store wrapped instruments in a designated sterile supply area that protects sterile items and their packaging from damage. This area should be clean, dry and free of contaminants. |
| Special Storage Condition, Specify | Between 0 and 0 *Store wrapped instruments in a designated sterile supply area that protects sterile items and their packaging from damage. This area should be clean, dry and free of contaminants. |
| Special Storage Condition, Specify | Between 0 and 0 *Store wrapped instruments in a designated sterile supply area that protects sterile items and their packaging from damage. This area should be clean, dry and free of contaminants. |
| Special Storage Condition, Specify | Between 0 and 0 *Store wrapped instruments in a designated sterile supply area that protects sterile items and their packaging from damage. This area should be clean, dry and free of contaminants. |
| Special Storage Condition, Specify | Between 0 and 0 *Store wrapped instruments in a designated sterile supply area that protects sterile items and their packaging from damage. This area should be clean, dry and free of contaminants. |
| Special Storage Condition, Specify | Between 0 and 0 *Store wrapped instruments in a designated sterile supply area that protects sterile items and their packaging from damage. This area should be clean, dry and free of contaminants. |
| Special Storage Condition, Specify | Between 0 and 0 *Store wrapped instruments in a designated sterile supply area that protects sterile items and their packaging from damage. This area should be clean, dry and free of contaminants. |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00890594000933 [Primary] |
| PWJ | Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00890594000933]
Dry Heat Sterilization
[00890594000933]
Dry Heat Sterilization
[00890594000933]
Dry Heat Sterilization
[00890594000933]
Dry Heat Sterilization
[00890594000933]
Dry Heat Sterilization
[00890594000933]
Dry Heat Sterilization
[00890594000933]
Dry Heat Sterilization
[00890594000933]
Dry Heat Sterilization
[00890594000933]
Dry Heat Sterilization
[00890594000933]
Dry Heat Sterilization
[00890594000933]
Dry Heat Sterilization
[00890594000933]
Dry Heat Sterilization
[00890594000933]
Dry Heat Sterilization
[00890594000933]
Dry Heat Sterilization
[00890594000933]
Dry Heat Sterilization
[00890594000933]
Dry Heat Sterilization
[00890594000933]
Dry Heat Sterilization
[00890594000933]
Dry Heat Sterilization
[00890594000933]
Dry Heat Sterilization
[00890594000933]
Dry Heat Sterilization
[00890594000933]
Dry Heat Sterilization
[00890594000933]
Dry Heat Sterilization
[00890594000933]
Dry Heat Sterilization
[00890594000933]
Dry Heat Sterilization
[00890594000933]
Dry Heat Sterilization
[00890594000933]
Dry Heat Sterilization
[00890594000933]
Dry Heat Sterilization
[00890594000933]
Dry Heat Sterilization
[00890594000933]
Moist Heat or Steam Sterilization
[00890594000933]
Moist Heat or Steam Sterilization
[00890594000933]
Moist Heat or Steam Sterilization
[00890594000933]
Moist Heat or Steam Sterilization
[00890594000933]
Moist Heat or Steam Sterilization
[00890594000933]
Moist Heat or Steam Sterilization
[00890594000933]
Moist Heat or Steam Sterilization
[00890594000933]
Moist Heat or Steam Sterilization
[00890594000933]
Moist Heat or Steam Sterilization
[00890594000933]
Moist Heat or Steam Sterilization
[00890594000933]
Moist Heat or Steam Sterilization
[00890594000933]
Moist Heat or Steam Sterilization
[00890594000933]
Moist Heat or Steam Sterilization
[00890594000933]
Moist Heat or Steam Sterilization
[00890594000933]
Moist Heat or Steam Sterilization
[00890594000933]
Moist Heat or Steam Sterilization
[00890594000933]
Moist Heat or Steam Sterilization
[00890594000933]
Moist Heat or Steam Sterilization
[00890594000933]
Moist Heat or Steam Sterilization
[00890594000933]
Moist Heat or Steam Sterilization
[00890594000933]
Moist Heat or Steam Sterilization
[00890594000933]
Moist Heat or Steam Sterilization
[00890594000933]
Moist Heat or Steam Sterilization
[00890594000933]
Moist Heat or Steam Sterilization
[00890594000933]
Moist Heat or Steam Sterilization
[00890594000933]
Moist Heat or Steam Sterilization
[00890594000933]
Moist Heat or Steam Sterilization
[00890594000933]
Moist Heat or Steam Sterilization
[00890594000933]
Moist Heat or Steam Sterilization
[00890594000933]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-11-13 |
| Device Publish Date | 2019-11-05 |
| 00857492008003 - Transobturator Helical, Left Introducer | 2022-08-11 Transobturator Helical, 3.2mm, Left Introducer is a surgical mesh instrument to be used in surgical procedures for the insertion |
| 00857492008010 - Transobturator Helical, Right Introducer | 2022-08-11 Transobturator Helical, 3.2mm, Right Introducer is a surgical mesh instrument to be used in surgical procedures for the insertio |
| 00857492008041 - Benesta Hysteroscope Set | 2022-08-11 Benesta Rod Lens Hysteroscope for viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and |
| 00857492008065 - Benesta Sterilization Tray | 2022-08-11 The Caldera Medical Benesta Sterilization Tray is intended to enclose, protect, and organize the Caldera Medical Benesta Rod Len |
| 00857492008133 - Benesta Sterilization Tray | 2022-08-11 The Caldera Medical Benesta Sterilization Tray is intended to enclose, protect, and organize the Caldera Medical Benesta Rod Len |
| 00890594000070 - Desara Blue SL | 2022-08-11 Desara® Blue SL sling system for female stress urinary incontinence. |
| 00890594000124 - Desara Blue TVez 3.0 | 2022-08-11 Desara Blue TVez 3.0mm for the treatment of female stress urinary incontinence (SUI) or mixed incontinence |
| 00890594000131 - Desara TVez 2.7 | 2022-08-11 Desara TVez 2.7mm for the treatment of female stress urinary incontinence (SUI) or mixed incontinence |