FDA UDI
In Commercial Distribution
🇺🇸 United States
Haag Streit UK
DI: 05060179470726
·
Model: 4701001
·
HAAG-STREIT UK LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
50
Basic Information
- Brand Name
- Haag Streit UK
- Primary DI
- 05060179470726
- Version / Model
- 4701001
- Catalog Number
- 4701001
- Company Name
- HAAG-STREIT UK LIMITED
- Labeler DUNS
- 504108242
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2016-07-22
- Public Version
- 3
- Public Version Date
- 2023-11-09
- Public Version Status
- Update
- Public Device Record Key
- ba373ce7-4d36-40c2-80d9-02c6b8501c66
Device Description
SCHIRMER TEAR TEST, PACK OF 50
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- No
- PM Exempt
- Yes
- 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 |
|---|---|---|---|---|
| KYD | Strip, Schirmer | Ophthalmic | 886.1800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37863 | Schirmer tear test strip | An ophthalmic device in the form of a small absorbent strip, made of filter paper or similar material, that is manually inserted under the patient's lower eyelid for a period of time to stimulate and evaluate the formation of tears. Commonly known as the Schirmer's test (ST), the device is used to provide a rapid lacrimal assessment for tearflow or tear volume. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05060179470726 | GS1 | ||||
| Unit of Use | 05060179470825 | GS1 |
Customer Contacts
- Phone
- +4401279414969
- [email protected]