FDA UDI
In Commercial Distribution
🇺🇸 United States
Anodyne Surgical
DI: 00840516110998
·
Model: 0022
·
Psi/Eye-Ko, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
100
Basic Information
- Brand Name
- Anodyne Surgical
- Primary DI
- 00840516110998
- Version / Model
- 0022
- Company Name
- Psi/Eye-Ko, Inc.
- Labeler DUNS
- 063763833
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2023-05-19
- Public Version
- 1
- Public Version Date
- 2023-05-29
- Public Version Status
- New
- Public Device Record Key
- 507cca3d-e05b-4ef2-be44-e6697aa17cef
Device Description
Sub Tenon Cannula 21g X 22mm (7/8") 7mm angled tip, tri port
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
- Yes
- 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
- Yes
- Sterilization Methods
- Radiation Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GAA | Needle, Aspiration And Injection, Disposable | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47610 | Ophthalmic needle, single-use | A slender, straight hollow instrument, usually with a sharp bevelled end, designed to be used with a syringe for the transient delivery of fluid materials (e.g., anaesthetic agents, therapeutic drugs) to various structures in and around the eye, including the eye muscles, or to an intraocular implant; it may also be intended for aspiration (e.g., aqueous humour). It is made of metal and/or plastic materials and may include a needle positioning and perforation depth guide. 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 | 00840516103471 | GS1 | ||||
| Primary | 00840516110998 | GS1 |
Customer Contacts
- Phone
- 1(800)428-5628
- [email protected]