FDA UDI
In Commercial Distribution
🇺🇸 United States
Omni-Tract®
DI: 10381780277293
·
Model: FLEXGEN1
·
INTEGRA LIFESCIENCES CORPORATION
Product Codes
3
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Omni-Tract®
- Primary DI
- 10381780277293
- Version / Model
- FLEXGEN1
- Catalog Number
- FLEXGEN1
- Company Name
- INTEGRA LIFESCIENCES CORPORATION
- Labeler DUNS
- 963856096
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-04-19
- Public Version
- 1
- Public Version Date
- 2018-05-21
- Public Version Status
- New
- Public Device Record Key
- 2caf0419-fc2e-4f78-b63f-f2bc6a1a72da
Device Description
Omni-Tract® Flex General Loaner System
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FGN | RETRACTOR, NON-SELF-RETAINING | Gastroenterology, Urology | 876.4730 | 1 |
| FFO | RETRACTOR, SELF-RETAINING | Gastroenterology, Urology | 876.4730 | 1 |
| GAD | RETRACTOR | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45181 | Surgical retraction system, reusable | A frame-like assembly of surgical instruments/devices intended to be used to create a self-locking, self-retaining mechanism to temporarily part tissue (e.g., hold the edges of an incision open) to expose internal tissues or organs for access during open surgery; is not intended for neurosurgery or ophthalmic surgery. It includes a mounting frame (e.g., bar, ring) and a number of detachable retracting blades, may include additional features (e.g., ratchet mechanisms, fibreoptic lights), and might be intended to be mounted to the operating table or be non-fixed. It is typically made of high-grade stainless steel and synthetic materials. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Secondary | M248FLEXGEN11 | HIBCC | ||||
| Primary | 10381780277293 | GS1 |
Customer Contacts
- Phone
- +1(800)654-2873
- [email protected]