FDA UDI
In Commercial Distribution
🇺🇸 United States
N/A
DI: 00850003089003
·
Model: 7001
·
Optalmed, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
5
Basic Information
- Brand Name
- N/A
- Primary DI
- 00850003089003
- Version / Model
- 7001
- Catalog Number
- 7001
- Company Name
- Optalmed, LLC
- Labeler DUNS
- 037077801
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2021-02-01
- Public Version
- 1
- Public Version Date
- 2021-02-09
- Public Version Status
- New
- Public Device Record Key
- 9fba354c-292e-484b-96d5-2b885df25389
Device Description
Disposable Iris Retractors, 1 set of 5 retractors
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 |
|---|---|---|---|---|
| HOC | Clip, Iris Retractor | Ophthalmic | 886.4350 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46698 | Intraocular retractor, single-use | A sterile, dedicated ophthalmic surgical instrument intended to be used explicitly for the temporary mechanical retraction/dilatation of intraocular tissues (e.g., iris) during ophthalmic surgery. It is typically a self-retaining ring/frame or a small hook-like device which may include a retention bead, and is usually designed to be manipulated using another ophthalmic instrument. 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 | 00850003089218 | GS1 | ||||
| Primary | 00850003089003 | GS1 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Caution
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from direct sunlight