FDA UDI
In Commercial Distribution
🇺🇸 United States
N.A.
DI: 04049368059585
·
Model: 15800
·
Geuder Aktiengesellschaft
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- N.A.
- Primary DI
- 04049368059585
- Version / Model
- 15800
- Catalog Number
- 15800
- Company Name
- Geuder Aktiengesellschaft
- Labeler DUNS
- 316267202
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-02-23
- Public Version
- 2
- Public Version Date
- 2021-06-08
- Public Version Status
- Update
- Public Device Record Key
- 81aefe96-b84a-4ea3-84d6-30fe9feac4e5
Device Description
N.A.
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
- 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
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HNQ | Hook, ophthalmic | Ophthalmic | 886.4350 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 12036 | Eye muscle hook, reusable | A hand-held manual surgical instrument designed to be used to locate and hook extraocular muscles, typically during strabismus correction surgery. It is a slender instrument with a bent blunt distal end and a handle, available in several sizes; some hooks with a very fine shank are designed to allow suture placement behind the hook, providing greater suture security (i.e., better muscle attachment). It is not designed for intraocular use. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04049368059585 | GS1 |