FDA UDI
In Commercial Distribution
🇺🇸 United States
Contact glass 901
DI: 07640132986280
·
Model: 901
·
Haag-Streit AG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Contact glass 901
- Primary DI
- 07640132986280
- Version / Model
- 901
- Catalog Number
- 1400273
- Company Name
- Haag-Streit AG
- Labeler DUNS
- 483467544
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 4
- Public Version Date
- 2022-06-17
- Public Version Status
- Update
- Public Device Record Key
- 46c090ea-2ce5-4869-9393-9dd5241232f5
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HJK | Lens, Contact, Polymethylmethacrylate, Diagnostic | Ophthalmic | 886.1385 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47946 | Ophthalmic diagnostic condensing lens | An ophthalmic lens intended to be used during binocular indirect ophthalmoscopy and/or slit lamp examination to focus reflected light from the fundus of the eye. The lens is available in a variety of sizes and optical powers. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07640132986280 | GS1 |
Customer Contacts
- Phone
- +41319780111
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K051103 | 000 |