FDA UDI
Not in Commercial Distribution
🇺🇸 United States
MEDI
DI: 00636257155141
·
Model: BK2S5N3
·
MEDI MANUFACTURING, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MEDI
- Primary DI
- 00636257155141
- Version / Model
- BK2S5N3
- Company Name
- MEDI MANUFACTURING, INC.
- Labeler DUNS
- 960754430
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-11-20
- Public Version
- 4
- Public Version Date
- 2021-11-23
- Public Version Status
- Update
- Public Device Record Key
- 82b71aa3-57b8-4447-a7d8-504a02273dda
- Distribution End Date
- 2020-04-20
Device Description
***DISC*30-40 STUMPSHRINKER BK 12" SHORT
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- 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 |
|---|---|---|---|---|
| IPM | COVER, LIMB | Physical Medicine | 890.3025 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 43222 | Limb-worn device hygienic cover | A device made of fabric or harder materials designed to cover an external prosthetic or orthotic device worn on a limb (e.g., cast, foot orthosis), or an external fixation system for a limb, primarily to function as a hygienic barrier to protect the device and patient from contamination; it is not intended to be applied directly to the limb for a therapeutic purpose. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00636257155141 | GS1 |
Customer Contacts
- Phone
- +1(800)633-6334
- [email protected]