FDA UDI
In Commercial Distribution
🇺🇸 United States
MediChoice
DI: 30885632113066
·
Model: IST1001
·
OWENS & MINOR DISTRIBUTION, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
10
Basic Information
- Brand Name
- MediChoice
- Primary DI
- 30885632113066
- Version / Model
- IST1001
- Company Name
- OWENS & MINOR DISTRIBUTION, INC.
- Labeler DUNS
- 007941230
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- 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
- 30a9f3d8-4ec0-49a5-9ac0-ead56e198f51
Device Description
Scissor Utility Polypropylene Handle Surgical Stanless Steel Blades Safety Tip Autoclaveable 7.25 Inch Not Made With Natural Rubber Latex MediChoice
Device Characteristics
- Single Use
- No
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KDC | INSTRUMENT, SURGICAL, DISPOSABLE | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 11791 | Dressing/utility forceps, scissors-like, reusable | A hand-held manual instrument designed primarily for non-dedicated grasping of devices, sponges and/or dressings during a procedure; it is neither intended for tissue manipulation nor endoscopic use. It has a scissors-like hinged design with ring handles and blades (non-cutting) that may be available in a range of sizes or designs. It may be intended for use at a specific anatomy. This is a reusable device intended to be sterilized prior to use. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50885632113060 | GS1 | 12 | In Commercial Distribution | ||
| Primary | 30885632113066 | GS1 | ||||
| Unit of Use | 10885632113062 | GS1 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in a cool dry place, free from direct sunlight
- Type
- Special Storage Condition, Specify