DeRoyal
- Primary DI
- 00749756013116
- Brand
- DeRoyal
- Company
- DEROYAL INDUSTRIES, INC.
- Model
- 6101-02
- Catalog number
- 6101-02
- Device description
- HEAD HALTER
- Published
- 2021-07-29
- 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
- false
Product Codes
| Code | Name |
|---|
| HSS | HALTER, HEAD, TRACTION |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| HSS | Halter, Head, Traction | Orthopedic | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00749756013116 | Primary | GS1 | 0 | |
Alternate GTIN/UPC/EAN values are derived from GS1 digit structure for lookup convenience. Do not treat derived UPC-A or EAN-13 values as separate FDA identifiers. GTIN-14 values with indicator digits 1-9 usually represent packaging levels, cases, pallets, or variable-measure items and are not converted to UPC-A/EAN-13 here.
Alternate GTIN / UPC / EAN Codes
| Source identifier | Source length | GTIN-14 normalized | Indicator | UPC-A | EAN-13 | Conversion note |
|---|
| 00749756013116 | 14 | 00749756013116 | 0 | 749756013116 | 0749756013116 | Indicator 0 and prefix 00 allow UPC-A and EAN-13 conversion. |
GMDN Terms
| Term | Definition |
|---|
| Traction system head halter | A device designed to provide traction to the cervical vertebrae by pulling the head with force from an external traction system. It typically combines several padded straps in a lightweight structure; usually one of the straps is placed under the chin, a second one on the back of the head, and another strap goes around the neck to attach the two other straps together. The device includes one or more rings at the top that permit its attachment to the traction system's cable. It is intended for horizontal and/or vertical traction and is used in orthopaedic and/or physical therapy procedures, including fracture treatment and widening of the intervertebral spaces in the spine. |
Regulatory Flags
- DUNS number
- 096372255
- Device count
- 1
- DM exempt
- true
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- 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
- true
- Sterilization required before use
- false
Other Devices From This Company
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|
| 00749756013109 | DeRoyal | DEROYAL INDUSTRIES, INC. | HSS | 2021-07-29 |
| 00749756013123 | DeRoyal | DEROYAL INDUSTRIES, INC. | HSS | 2021-07-29 |
| 00749756013130 | DeRoyal | DEROYAL INDUSTRIES, INC. | HSS | 2021-07-29 |
| 00749756013147 | DeRoyal | DEROYAL INDUSTRIES, INC. | HSS | 2021-07-29 |
| 50749756013159 | DeRoyal | DEROYAL INDUSTRIES, INC. | HSS | 2021-07-29 |
| 50749756013166 | DeRoyal | DEROYAL INDUSTRIES, INC. | HSS | 2021-07-29 |
| 00749756013208 | DeRoyal | DEROYAL INDUSTRIES, INC. | HSS | 2021-07-29 |
| 00749756015608 | DeRoyal | DEROYAL INDUSTRIES, INC. | HSS | 2021-07-29 |
| 00749756015615 | DeRoyal | DEROYAL INDUSTRIES, INC. | HSS | 2021-07-29 |
| 00749756878449 | DeRoyal | DEROYAL INDUSTRIES, INC. | HSS | 2021-07-20 |
| 50749756031542 | DeRoyal | DEROYAL INDUSTRIES, INC. | HSS | 2021-06-30 |
| 00724995165079 | NA | STERIS CORPORATION | HSS | 2021-04-23 |
| 00889024373518 | NA | ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC. | HSS | 2021-03-03 |
| 00889024373587 | NA | ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC. | HSS | 2021-03-03 |
| 00822383302980 | DRIVEMEDICAL | Drive Devilbiss Healthcare | HSS | 2019-06-21 |
| 00822383561738 | Drive | Drive Devilbiss Healthcare | HSS | 2019-06-21 |
| 00842430106194 | Assy, Head Halter and Chin Cup | MIZUHO ORTHOPEDIC SYSTEMS, INC. | HSS | 2019-01-18 |
| 10842430106207 | HEAD HALTER, DISPOSABLE | MIZUHO ORTHOPEDIC SYSTEMS, INC. | HSS | 2018-10-17 |
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