FDA UDI
In Commercial Distribution
🇺🇸 United States
Monofilament, Fine
DI: 00632307002182
·
Model: PD100.06
·
Peregrine Surgical, Llc
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Monofilament, Fine
- Primary DI
- 00632307002182
- Version / Model
- PD100.06
- Company Name
- Peregrine Surgical, Llc
- Labeler DUNS
- 622467348
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-01-10
- Public Version
- 5
- Public Version Date
- 2024-09-11
- Public Version Status
- Update
- Public Device Record Key
- 2aa3f224-7e4e-4c3c-a53b-7f5e2531466f
Device Description
Monofilament, Fine
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
- Yes
- 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 |
|---|---|---|---|---|
| MPA | Endoilluminator | Gastroenterology, Urology | 876.1500 | 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 | 10632307002189 | GS1 | 5 | In Commercial Distribution | ||
| Primary | 00632307002182 | GS1 |
Customer Contacts
- Phone
- 215-348-0456
- [email protected]
- Phone
- 215-348-0456
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K980797 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Needle Gauge | 20 | Gauge |