FDA UDI
In Commercial Distribution
🇺🇸 United States
MEDLINE INDUSTRIES
DI: 10884389024218
·
Model: DYNJBW26
·
MEDLINE INDUSTRIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- MEDLINE INDUSTRIES
- Primary DI
- 10884389024218
- Version / Model
- DYNJBW26
- Catalog Number
- DYNJBW26
- Company Name
- MEDLINE INDUSTRIES, INC.
- Labeler DUNS
- 025460908
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-04-24
- Public Version
- 1
- Public Version Date
- 2024-05-02
- Public Version Status
- New
- Public Device Record Key
- 22af4c2e-fbb7-4ed4-a64a-d02fb6fb8641
Device Description
WAX,BONE,SYNTHETIC
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
- 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 |
|---|---|---|---|---|
| MTJ | Wax, bone | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44811 | Bone wax, synthetic | A sterile, implantable device in the form of a sterile wax-like, putty-like, or paste material designed to stop bone bleeding by the creation of a physical barrier along the edges of bone that has been damaged by trauma or cut during a surgical procedure. When placed on the bone under moderate pressure it plugs the vascular openings in the bone and prevents further bleeding. It is typically made from biocompatible/bioabsorbable synthetic substances (e.g., water-soluble copolymers); its stickiness may be increased by warming and by additional handling and manipulation. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30884389024212 | GS1 | BX | 12 | In Commercial Distribution | |
| Primary | 10884389024218 | GS1 |
Customer Contacts
- Phone
- +1(800)633-5463
- [email protected]
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 21 – 23 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Protect from freezing. Avoid excessive heat. Shield from direct sunlight. Keep Dry.