Surgical Instrument
- Primary DI
- 08809282819056
- Brand
- Surgical Instrument
- Company
- Jeil Medical Corporation
- Model
- Bandage-M
- Published
- 2021-11-23
- 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 |
|---|
| FQM | Bandage, Elastic |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| FQM | Bandage, Elastic | General Hospital | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 08809282819056 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|
| 08809282819056 | 08809282819056 | 8809282819056 |
GMDN Terms
| Term | Definition |
|---|
| Pressure bandage, non-latex, reusable | A strip or roll of fabric or plastic material intended to be applied to and compress a local area of the body for one or more preventative/therapeutic applications (e.g., treatment of lymphoedema, venous oedema and lipoedema, support injuries associated with minor trauma), and/or to secure hot/cold packs to the body to provide heat/cold therapy. It may be described as a sports tape intended for support while allowing movement, or described as a compression bandage; it is not intended to be used in association with open wounds. It is intended for use in the home or healthcare facility. This is a reusable device. |
Sterilization Methods
| Method |
|---|
| Moist Heat or Steam Sterilization |
Regulatory Flags
- DUNS number
- 688811603
- 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
- true
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|---|
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| 08800089480159 | Summa Orthopaedics Femur Nail System | SO-SPFL-A085 | | 2026-02-23 |
| 08800089480166 | Summa Orthopaedics Femur Nail System | SO-SPFL-A090 | | 2026-02-23 |
| 08800089480173 | Summa Orthopaedics Femur Nail System | SO-SPFL-A095 | | 2026-02-23 |
| 08800089480180 | Summa Orthopaedics Femur Nail System | SO-SPFL-A100 | | 2026-02-23 |
| 08800089480197 | Summa Orthopaedics Femur Nail System | SO-SPFL-A105 | | 2026-02-23 |
| 08800089480203 | Summa Orthopaedics Femur Nail System | SO-SPFL-A110 | | 2026-02-23 |
| 08800089480210 | Summa Orthopaedics Femur Nail System | SO-SPFL-A115 | | 2026-02-23 |
| 08800089480227 | Summa Orthopaedics Femur Nail System | SO-SPFL-A120 | | 2026-02-23 |
| 08800089480234 | Summa Orthopaedics Femur Nail System | SO-SPFL-A125 | | 2026-02-23 |
| 08800089480241 | Summa Orthopaedics Femur Nail System | SO-SPFL-A130 | | 2026-02-23 |
| 08800089480258 | Summa Orthopaedics Femur Nail System | SO-SPFL-T085 | | 2026-02-23 |
| 08800089480265 | Summa Orthopaedics Femur Nail System | SO-SPFL-T090 | | 2026-02-23 |
| 08800089480272 | Summa Orthopaedics Femur Nail System | SO-SPFL-T095 | | 2026-02-23 |
| 08800089480289 | Summa Orthopaedics Femur Nail System | SO-SPFL-T100 | | 2026-02-23 |
| 08800089480296 | Summa Orthopaedics Femur Nail System | SO-SPFL-T105 | | 2026-02-23 |
| 08800089480302 | Summa Orthopaedics Femur Nail System | SO-SPFL-T110 | | 2026-02-23 |
| 08800089480319 | Summa Orthopaedics Femur Nail System | SO-SPFL-T115 | | 2026-02-23 |
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