FDA UDI
In Commercial Distribution
🇺🇸 United States
Medichoice
DI: 10885632114649
·
Model: LHC1002
·
OWENS & MINOR DISTRIBUTION, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
2
Basic Information
- Brand Name
- Medichoice
- Primary DI
- 10885632114649
- Version / Model
- LHC1002
- Company Name
- OWENS & MINOR DISTRIBUTION, INC.
- Labeler DUNS
- 007941230
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 2
- Record Status
- Published
- Publish Date
- 2016-08-20
- Public Version
- 5
- Public Version Date
- 2022-11-09
- Public Version Status
- Update
- Public Device Record Key
- 482367ad-546f-439a-bdb0-bef0798c89d2
Device Description
Cover Light Handle Flexible 2 Per Pack Sterile Not Made With Natural Rubber Latex MediChoice
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- 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
- No
- 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 |
|---|---|---|---|---|
| FTA | Light, surgical, accessories | General, Plastic Surgery | 878.4580 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44977 | Medical equipment handle cover, single-use | A device designed specifically to cover the handle of a piece of medical equipment (e.g., operating light) to provide a physical sterile barrier between the handle and the hand of a healthcare professional, e.g., during a surgical procedure. It is typically a polymer device designed for attachment to a handle and may in addition provide grip for improved manipulation of the handle; it is not designed to cover other equipment components. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50885632114647 | GS1 | 80 | In Commercial Distribution | ||
| Primary | 10885632114649 | GS1 | ||||
| Unit of Use | 60885632114644 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K053321 | 000 |