FDA UDI
In Commercial Distribution
🇺🇸 United States
Medline
DI: 10888277388192
·
Model: 5093130R
·
MEDLINE INDUSTRIES, INC.
Product Codes
1
GMDN Terms
2
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Medline
- Primary DI
- 10888277388192
- Version / Model
- 5093130R
- Catalog Number
- 5093130R
- Company Name
- MEDLINE INDUSTRIES, INC.
- Labeler DUNS
- 025460908
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-10-09
- Public Version
- 1
- Public Version Date
- 2023-10-17
- Public Version Status
- New
- Public Device Record Key
- c34df50e-c59b-45fb-ad38-a453a60cd0c3
Device Description
5093-130 HALL MICRO BUR,RND,X-LONG,1
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 |
|---|---|---|---|---|
| GFF | BUR, SURGICAL, GENERAL & PLASTIC SURGERY | General, Plastic Surgery | 878.4820 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61805 | Sternum saw blade, reprocessed | A flat metal surgical instrument with a serrated edge intended to be attached to a dedicated powered surgical saw for cutting the sternum (the breastbone) during cardiovascular surgery. It is available in various forms (e.g., straight or arc-shaped) and is powered by a rapid reciprocating, oscillating or sagittal motion provided by the saw. This is a previously used single-use device that has been processed for an additional single-use patient application. | No | Active |
| 45553 | Orthopaedic bur, single-use | A sterile, rotary cutting device consisting of a shaft of high-grade steel and a cutting head of hard metal/material with fluting or cutting planes of various shapes at the working end and which is designed to fit into an appropriate powered handpiece that provides the rotation allowing the user to excavate/shape bone tissue during small and large bone surgery (e.g., maxillofacial, spinal, or orthopaedic). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20888277388199 | GS1 | BX | 5 | In Commercial Distribution | |
| Primary | 10888277388192 | GS1 |
Customer Contacts
- Phone
- +1(800)633-5463
- [email protected]