PremierPro
- Primary DI
- 10818566010299
- Brand
- PremierPro
- Company
- SVS LLC
- Model
- 7753
- Catalog number
- 7753
- Device description
- Crutches, Bariatric, Adult, pair Crutch Height 47" - 55" Patient Height 5'2" - 5'10"
- Published
- 2020-08-26
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- false
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| IPR | Crutch | Physical Medicine | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 10818566010299 | Package | GS1 | 4 | In Commercial Distribution |
| 00818566010292 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 10818566010299 | 10818566010299 | | |
| 00818566010292 | 00818566010292 | 818566010292 | 0818566010292 |
GMDN Terms
| Term | Definition |
|---|
| Axillary crutch | A staff-like mobility aid used to assist a person with a disability to support their weight while walking. The device has one leg, a padded hand support at the level of the user's wrist, and an under-arm (the armpit or axilla) padded platform. The pads are typically made of non-slip material (e.g., rubber, glycerin gel, sheepskin). The device may be adjustable in length and is typically made of wood or metal [e.g., aluminium (Al), titanium (Ti)]. |
Regulatory Flags
- DUNS number
- 831375089
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- false
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- true
- Sterilization required before use
- false
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| 10860009370613 | Medzah Aluminum Crutches Medium | Medzah Industries | IPR | 2024-01-23 |
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| 10810113574827 | VIVE | VIVE HEALTH LLC | IPR | 2023-11-13 |
| 06940979190033 | LUYAO | Zhejiang Luyao Electronics Technology Co., Ltd. | IPR | 2023-08-29 |
| 10810113574025 | Vive | VIVE HEALTH LLC | IPR | 2023-08-23 |
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| 10810113574049 | Vive | VIVE HEALTH LLC | IPR | 2023-08-23 |
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| 10810132041546 | HCS | Concordance Healthcare Solutions LLC | IPR | 2023-06-23 |
| 10810132041553 | HCS | Concordance Healthcare Solutions LLC | IPR | 2023-06-23 |
| 10810132041560 | HCS | Concordance Healthcare Solutions LLC | IPR | 2023-06-23 |
| 10810132041577 | HCS | Concordance Healthcare Solutions LLC | IPR | 2023-06-23 |
| 00850051333042 | GAESCA | Mp2g Diagnostic Corp | IPR | 2023-04-27 |
| 00850051333059 | GAESCA | Mp2g Diagnostic Corp | IPR | 2023-04-27 |
| 00850051333066 | GAESCA | Mp2g Diagnostic Corp | IPR | 2023-04-27 |
| 10057475060340 | BIOS Living | Thermor Ltd | IPR | 2023-03-31 |
| 10057475060357 | BIOS Living | Thermor Ltd | IPR | 2023-03-31 |
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