FDA UDI
In Commercial Distribution
🇺🇸 United States
AQUALOC®
DI: 08428898885622
·
Model: 900364H
·
Biomet Orthopedics, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
6
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Basic Information
- Brand Name
- AQUALOC®
- Primary DI
- 08428898885622
- Version / Model
- 900364H
- Catalog Number
- 900364H
- Company Name
- Biomet Orthopedics, LLC
- Labeler DUNS
- 129278169
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 6
- Record Status
- Published
- Publish Date
- 2020-05-20
- Public Version
- 2
- Public Version Date
- 2025-05-30
- Public Version Status
- Update
- Public Device Record Key
- 4ab04330-7cd2-425e-bf59-039e76d55913
Device Characteristics
- Single Use
- Yes
- 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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GEA | CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58752 | Arthroscopic access cannula, single-use | A single-lumen surgical device intended to be percutaneously inserted into a joint to create an access port for an arthroscope/arthroscopic instrument during arthroscopy. The cannula is designed to facilitate the passage of surgical instruments while preventing the escape of irrigation fluid and typically includes an internal watertight seal, and a port for drainage of fluid. It is available in a variety of dimensions and/or designs and may include one or more obturator(s) to facilitate insertion. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 78428898885621 | GS1 | ||||
| Primary | 08428898885622 | GS1 |
Customer Contacts
- Phone
- +1(800)348-9500
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 7 MM 85 MM |