FDA UDI
In Commercial Distribution
🇺🇸 United States
NeoDevices, Inc.
DI: 10816340021066
·
Model: NDF2C
·
NEODEVICES INC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- NeoDevices, Inc.
- Primary DI
- 10816340021066
- Version / Model
- NDF2C
- Company Name
- NEODEVICES INC
- Labeler DUNS
- 189670230
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- fcd85139-ded4-43de-a671-5164c4cc5e41
Device Description
Curved Graefe forceps
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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HRN | Unit, Cryophthalmic, Ac-Powered | Ophthalmic | 886.4170 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 11798 | Utility forceps, reusable | A hand-held manual surgical instrument used for general-purpose grasping/picking up of other devices/objects typically with the intention of maintaining a sterile condition or avoiding direct hand contact because of unhygienic/unfavourable conditions. It typically has a scissors-like design with ring handles and is made of high-grade stainless steel. It is available in various sizes and the working end will typically have grasping blades that are elongated or shaped as large oval or triangular rings. The blades are usually serrated to enhance grip on the objects being picked up. This is a reusable device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10816340027891 | GS1 | 10 | In Commercial Distribution | ||
| Primary | 10816340021066 | GS1 |
Customer Contacts
- Phone
- 866-636-6285
- [email protected]