FDA UDI
In Commercial Distribution
🇺🇸 United States
MEDLINE
DI: 10888277408739
·
Model: 5DCDR
·
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
- 10888277408739
- Version / Model
- 5DCDR
- Catalog Number
- 5DCDR
- Company Name
- MEDLINE INDUSTRIES, INC.
- Labeler DUNS
- 025460908
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-01-30
- Public Version
- 1
- Public Version Date
- 2025-02-07
- Public Version Status
- New
- Public Device Record Key
- b28b5ac4-f6eb-45ff-88c8-a1383f55f27c
Device Description
5DCD @ENDPH ENDOSCOPIC INSTRUMENT CURVED
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
- No
- 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 |
|---|---|---|---|---|
| NUJ | Electrosurgical, cutting & coagulation accessories, laparoscopic & endoscopic, reprocessed | General, Plastic Surgery | 878.4400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61815 | Endoscopic electrosurgical handpiece/electrode, monopolar, reprocessed | A sterile electrosurgical device which consists of a handpiece with mechanical and/or electrical controls, and a monopolar electrode, intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery. It includes a long thin electrode connected to the handpiece, and may include a lumen for suction/irrigation; it is available in a variety of forms (e.g., forceps, probe with controls) and requires a patient contact return electrode to complete the circuit. This is a previously used single-use device that has been processed for an additional single-use patient application. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20888277408736 | GS1 | CS | 6 | In Commercial Distribution | |
| Primary | 10888277408739 | GS1 |
Customer Contacts
- Phone
- +1(800)633-5463
- [email protected]