FDA UDI
In Commercial Distribution
🇺🇸 United States
Medichoice
DI: 10885632101595
·
Model: HS0813
·
OWENS & MINOR DISTRIBUTION, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Medichoice
- Primary DI
- 10885632101595
- Version / Model
- HS0813
- Company Name
- OWENS & MINOR DISTRIBUTION, INC.
- Labeler DUNS
- 007941230
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-20
- Public Version
- 6
- Public Version Date
- 2023-11-27
- Public Version Status
- Update
- Public Device Record Key
- d5624915-d345-4f95-8402-404f21c9cbcc
Device Description
Pouch Sterilization Heat-Seal Ethylene Oxide Steam Dual Indicator Blue-Tinted Kraft Paper 8 X 13 Inch 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
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FRG | Wrap, sterilization | General Hospital | 880.6850 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60908 | Sterilization container liner | A non-sterile device intended to be used to line containers used for steam or solvent sterilization (e.g., trays, wraps, pouches) to absorb moisture and protect the container's finish. It is typically made of an absorbent, non-woven material or paper. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50885632101593 | GS1 | 5 | In Commercial Distribution | ||
| Package | 30885632101599 | GS1 | 200 | In Commercial Distribution | ||
| Primary | 10885632101595 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K112591 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 8 | Inch | |
| Width | 13 | Inch |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Avoid Direct Sunlight, Avoid Rain
- Type
- Special Storage Condition, Specify