FDA UDI
In Commercial Distribution
🇺🇸 United States
MediChoice
DI: 20885632065412
·
Model: SG0001
·
OWENS & MINOR DISTRIBUTION, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
3
Basic Information
- Brand Name
- MediChoice
- Primary DI
- 20885632065412
- Version / Model
- SG0001
- Company Name
- OWENS & MINOR DISTRIBUTION, INC.
- Labeler DUNS
- 007941230
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 3
- Record Status
- Published
- Publish Date
- 2020-09-23
- Public Version
- 1
- Public Version Date
- 2020-10-01
- Public Version Status
- New
- Public Device Record Key
- b4683ed6-898b-4ec5-96d9-e13d6517ccc7
Device Description
Suture Guide Curved 8 Numbered A And B Slots Single Patient Use, Sterile White Hdpe Base, Blue Pvc Insert, White Foam Tape With High Tack Adhesive, White Paper Liner 3 Per Pack MediChoice
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
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| GEJ | CARRIER, LIGATURE | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 13895 | Operative-site suture holder | A device designed to hold suture threads to facilitate their manipulation, positioning and differentiation around the operative site during a surgical procedure. It typically has a circular, oval, or curved shape with grooves or other connecting elements, and is stabilized by attachment to a surgical drape; it may also be attached to an invasive surgical retractor. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30885632065419 | GS1 | 4 | In Commercial Distribution | ||
| Primary | 20885632065412 | GS1 | ||||
| Unit of Use | 10885632065415 | GS1 |