FDA UDI
In Commercial Distribution
🇺🇸 United States
Medline
DI: 10888277377172
·
Model: AR198008SRH
·
MEDLINE INDUSTRIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Medline
- Primary DI
- 10888277377172
- Version / Model
- AR198008SRH
- Catalog Number
- AR198008SRH
- Company Name
- MEDLINE INDUSTRIES, INC.
- Labeler DUNS
- 025460908
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-04-08
- Public Version
- 1
- Public Version Date
- 2022-04-18
- Public Version Status
- New
- Public Device Record Key
- 543cf3c9-ca85-41cf-83d4-b660eafe3ae0
Device Description
AR-1980-08S OSTEOCHONDRAL AUTOGRAFT TRA
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
- 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
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LXH | Orthopedic manual surgical instrument | Orthopedic | 888.4540 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47939 | Bone autograft | Bone intended for transplantation that is harvested from the body of the recipient and subjected to processing with a method and/or exogenous material to modify the tissue prior to permanent implantation. The bone is implanted to provide osteogenesis and/or for structural bone replacement during plastic (reconstructive/augmentation) surgery. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10888277377172 | GS1 |
Customer Contacts
- Phone
- +1(800)633-5463
- [email protected]