FDA UDI
In Commercial Distribution
🇺🇸 United States
27GA Midfield Endoillumination Probe
DI: 00632307002366
·
Model: 3269.M04-00
·
Peregrine Surgical, Llc
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- 27GA Midfield Endoillumination Probe
- Primary DI
- 00632307002366
- Version / Model
- 3269.M04-00
- Company Name
- Peregrine Surgical, Llc
- Labeler DUNS
- 622467348
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-09-24
- Public Version
- 1
- Public Version Date
- 2024-10-02
- Public Version Status
- New
- Public Device Record Key
- 51bf5f7b-ff05-410c-8b76-6b09d94fae6f
Device Description
27GA Midfield Endoillumination Probe
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
- Yes
- PM Exempt
- No
- 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
- Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HJM | Transilluminator, Ac-Powered | Ophthalmic | 886.1945 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45193 | Ophthalmic fibreoptic light instrument, single-use | A sterile, hand-held, ophthalmic surgical instrument with a thin, rigid, insertion portion, that is inserted into the eye during a surgical intervention for the purpose of conducting a field of cold light to the posterior segment of the eye. It is connected through a permanently attached light cable to a light source. It has a fibreoptic bundle core that conducts the light, and may be provided with an atraumatic tip to allow for extraocular manipulation (orbital depression) with transscleral illumination. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10632307002363 | GS1 | Box | 6 | In Commercial Distribution | |
| Primary | 00632307002366 | GS1 |
Customer Contacts
- Phone
- +1(215)348-0456
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K233653 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Needle Gauge | 27 | Gauge | |
| Device Size Text, specify | 27 Gauge Needle |