GEMS
- Primary DI
- 00618125162178
- Brand
- GEMS
- Company
- TIDI PRODUCTS, LLC
- Model
- 23531
- Device description
- Infant Positioner Head Straps, Set of 3
- Published
- 2016-11-18
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- false
Related Records
Product Codes
| Code | Name |
|---|---|
| IWY | Holder, Head, Radiographic |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| IWY | Holder, Head, Radiographic | Radiology | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00618125162178 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00618125162178 | 00618125162178 | 618125162178 | 0618125162178 |
GMDN Terms
| Term | Definition |
|---|---|
| Arm restraint | A non-rigid device, typically a strap or band made of various materials (e.g., fabric, nylon, leather, foam), used to temporarily secure a patient's arm(s) to a fixture or furniture part (e.g., bedrail, chair, table leg) to restrict the patient's physical activity for the prevention of potential injury or hazards. This is a reusable device. |
Sterilization Methods
| Method |
|---|
Regulatory Flags
- DUNS number
- 063519193
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- true
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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| 10618125192271 | Steris | 31780 N/S | BF459 (056404-709) | 2025-07-01 |
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| 00618125192182 | Grip-Lok | 3400L-10PK | 3400L-10PK | 2024-12-02 |
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