FDA UDI
In Commercial Distribution
🇺🇸 United States
MEDLINE
DI: 10653160384557
·
Model: DYND04145
·
MEDLINE INDUSTRIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- MEDLINE
- Primary DI
- 10653160384557
- Version / Model
- DYND04145
- Catalog Number
- DYND04145
- Company Name
- MEDLINE INDUSTRIES, INC.
- Labeler DUNS
- 025460908
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-01-16
- Public Version
- 1
- Public Version Date
- 2025-01-24
- Public Version Status
- New
- Public Device Record Key
- 2971a521-6870-44f0-9ac7-1aaf99669e8f
Device Description
CHILD MAGILL FCP
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- Yes
- PM Exempt
- No
- 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 |
|---|---|---|---|---|
| LRO | General surgery tray | General, Plastic Surgery | 878.4370 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33089 | Airway tube forceps, single-use | A sterile, hand-held instrument used for grasping a tube [e.g., a catheter or an endotracheal (ET) tube] for its insertion and/or extraction into/from the airways, or for grasping obstructive objects for their removal from the airways. Commonly known as a Magill's forceps, it typically has a scissors-like design with ring handles and is made of strong disposable plastic materials or stainless steel. It is available in various sizes and the working end will typically have grasping blades that have small ringed loops or S-shaped distal working ends. The blades are serrated to provide extra grip. It is typically used by emergency medical services (EMS). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00653160384550 | GS1 | CASE | 25 | In Commercial Distribution | |
| Primary | 10653160384557 | GS1 |
Customer Contacts
- Phone
- +1(800)633-5463
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K213481 | 000 |