FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: 07613252085591
·
Model: 89131
·
Stryker Leibinger GmbH & Co. KG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- NA
- Primary DI
- 07613252085591
- Version / Model
- 89131
- Catalog Number
- 89131
- Company Name
- Stryker Leibinger GmbH & Co. KG
- Labeler DUNS
- 316153956
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-24
- Public Version
- 3
- Public Version Date
- 2020-10-12
- Public Version Status
- Update
- Public Device Record Key
- 5ce79cf6-f1ca-4206-a376-bfb926b29bc8
Device Description
Natural-Iris Conformer Color #6 Medium
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
- 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
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HQN | CONFORMER, OPHTHALMIC | Ophthalmic | 886.3130 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16065 | Ophthalmic conformer | An ophthalmic device, typically constructed from moulded plastic, that is intended to be inserted temporarily between the eyeball and eyelid to maintain space in the orbital cavity and prevent closure or adhesions during the healing process following eye surgery. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07613252085591 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K972034 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Height | 22.0 | Millimeter | |
| Width | 26.0 | Millimeter |