FDA UDI
In Commercial Distribution
🇺🇸 United States
Avalign
DI: 10190776002678
·
Model: VM29-5113C
·
Avalign Technologies, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
18
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Basic Information
- Brand Name
- Avalign
- Primary DI
- 10190776002678
- Version / Model
- VM29-5113C
- Company Name
- Avalign Technologies, Inc.
- Labeler DUNS
- 792528510
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 18
- 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
- a8a0883f-2c59-40a0-8c68-72cd010a696a
Device Description
Bookwalter Ring Retractor Set 2C
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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 |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| Primary | 10190776002678 | GS1 | ||||
| Unit of Use | 00190776002671 | GS1 |
Customer Contacts
- Phone
- +1(877)289-1096
- [email protected]