FDA UDI
In Commercial Distribution
🇺🇸 United States
Avalign
DI: 10190776016200
·
Model: VM84-26325
·
Avalign Technologies, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
2
Basic Information
- Brand Name
- Avalign
- Primary DI
- 10190776016200
- Version / Model
- VM84-26325
- Company Name
- Avalign Technologies, Inc.
- Labeler DUNS
- 792528510
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 2
- Record Status
- Published
- Publish Date
- 2017-03-23
- Public Version
- 3
- Public Version Date
- 2023-07-06
- Public Version Status
- Update
- Public Device Record Key
- 9f38c771-73d6-4526-baf4-b562ffd3e10f
Device Description
McCulloch Type Narrow Muscle Blade, pair
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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| GZT | RETRACTOR, SELF-RETAINING, FOR NEUROSURGERY | Neurology | 882.4800 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45182 | Self-retaining surgical retractor, reusable | A hand-operated, self-retaining, one-piece surgical instrument intended to be used to separate/draw aside the margins of a wound/incision to allow access to tissues/organs during open surgery; it is not intended to retract the ribs and is not dedicated to ophthalmic surgery, but may otherwise be clinically dedicated. It is designed as a one-piece device (i.e., not a mounting ring, or table-fixed assembly) having two legs with distal hooked blades and a self-retaining mechanism to maintain the legs in an open position for retraction. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10190776016200 | GS1 | ||||
| Unit of Use | 00190776016203 | GS1 |
Customer Contacts
- Phone
- +1(877)289-1096
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 40 | Millimeter |