FDA UDI
In Commercial Distribution
🇺🇸 United States
GREAT WHITE MERLIN
DI: 10845854033692
·
Model: 37GRW-ME-ZZ
·
Conmed Corporation
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
6
Basic Information
- Brand Name
- GREAT WHITE MERLIN
- Primary DI
- 10845854033692
- Version / Model
- 37GRW-ME-ZZ
- Catalog Number
- 37GRW-ME-ZZ
- Company Name
- Conmed Corporation
- Labeler DUNS
- 071595540
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 6
- Record Status
- Published
- Publish Date
- 2020-09-24
- Public Version
- 6
- Public Version Date
- 2023-01-19
- Public Version Status
- Update
- Public Device Record Key
- 1a1bf1ef-b9b4-4429-be53-d6cbec632085
Device Description
3.7 MM GREAT WHITE MERLIN, BENDABLE TO 30 DEGREE
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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GFA | BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL | General, Plastic Surgery | 878.4820 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 12143 | Instrument tray, reusable | A container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20845854033699 | GS1 | CARTON | 6 | In Commercial Distribution | |
| Primary | 10845854033692 | GS1 | ||||
| Unit of Use | 00845854033695 | GS1 |
Customer Contacts
- Phone
- +1(866)426-6633
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 3.7 | Millimeter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- KEEP DRY