Medline Industries, Inc.
- Primary DI
- 10198459130656
- Brand
- Medline Industries, Inc.
- Company
- MEDLINE INDUSTRIES, INC.
- Model
- DYNJ910199A
- Catalog number
- DYNJ910199A
- Device description
- C-SECTION
- Published
- 2024-09-22
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- true
Product Codes
| Code | Name |
|---|
| OHM | Cesarean section tray |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| OHM | Cesarean Section Tray | Obstetrics/Gynecology | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 10198459130656 | Primary | GS1 | 0 | |
GMDN Terms
| Term | Definition |
|---|
| General surgical procedure kit, non-medicated, single-use | A typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device. |
Contacts
| Phone | Email |
|---|
| +1(800)633-5463 | customerservice@medline.com |
Regulatory Flags
- DUNS number
- 025460908
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- true
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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