FDA UDI
In Commercial Distribution
🇺🇸 United States
YEOH SIDEPORT GAUGE
DI: 00841668127797
·
Model: AE-1572T
·
KATENA PRODUCTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- YEOH SIDEPORT GAUGE
- Primary DI
- 00841668127797
- Version / Model
- AE-1572T
- Catalog Number
- AE-1572T
- Company Name
- KATENA PRODUCTS, INC.
- Labeler DUNS
- 085668598
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-07
- Public Version
- 1
- Public Version Date
- 2022-12-15
- Public Version Status
- New
- Public Device Record Key
- aa96c9a3-6920-4ed0-b902-b95f40408db9
Device Description
YEOH SIDEPORT GAUGE
Device Characteristics
- Single Use
- No
- 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
- No
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| HOE | Caliper, ophthalmic | Ophthalmic | 886.4350 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63538 | Ophthalmic surgical incision gauge | A manual surgical instrument intended to be used during an ophthalmic surgical procedure to measure the length of an incision made on the surface of the eye (cornea or sclera). It typically consists of a hand-held metal tool with graduations. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00841668127797 | GS1 |
Customer Contacts
- Phone
- +1(973)989-1600
- [email protected]