CEMSTOP INSTRUMENTATION
- Primary DI
- 03760177040274
- Brand
- CEMSTOP INSTRUMENTATION
- Company
- TEKNIMED
- Model
- Trial plug DIAMETER 12 mm
- Catalog number
- T067704
- Published
- 2020-09-28
- 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
Related Records
Product Codes
| Code | Name |
|---|---|
| LXH | Orthopedic Manual Surgical Instrument |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| LXH | Orthopedic Manual Surgical Instrument | Orthopedic | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 03760177040274 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 03760177040274 | 03760177040274 | 3760177040274 |
GMDN Terms
| Term | Definition |
|---|---|
| Orthopaedic cement restrictor sizer | A non-sterile, hand-held manual orthopaedic surgical instrument designed to be used to measure the diameter of the medullary canal of a bone (e.g., femur, humerus) in order to select the appropriate size orthopaedic cement restrictor implant. It may be in the form of a trial prosthesis attached to an inserter, or a rod with a measuring gauge at the distal end. This is a reusable device intended to be sterilized prior to use. |
Sterilization Methods
| Method |
|---|
| Moist Heat or Steam Sterilization |
Regulatory Flags
- DUNS number
- 764746723
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- true
- 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
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 03701505801204 | Dynamo | Spinal Cement – MV | 11-5920 | 2026-02-02 |
| 03701505801211 | Dynamo | Spinal Cement System Syringe MV 1.5cc | 11-5921 | 2026-02-02 |
| 03701505801228 | Dynamo | Spinal Cement System Syringe MV 4cc | 11-5922 | 2026-02-02 |
| 03701505801235 | Dynamo | Spinal Cement System Gun MV | 11-5923 | 2026-02-02 |
| 03760177044326 | Signature -x Cement | SV | P/N191-14-4000 | 2026-01-23 |
| 03760177044333 | Signature -x Cement | LV | P/N191-14-4001 | 2026-01-23 |
| 03760177044340 | Signature -x Cement | MV | MVP/N191-14-4002 | 2026-01-23 |
| 03760177040090 | GENTAFIX | 1 | T040140G | 2025-09-02 |
| 03760177040137 | GENTAFIX | 3 | T040340G | 2025-09-02 |
| 03760177043176 | GENTAFIX | 3 MV | T040341G | 2025-09-02 |
| 03701505801020 | PureKit Syringe 1.5cc MV | T060428MV | 2025-03-31 | |
| 03701505801037 | META+ System 1.5cc MV | T040352MV | 2025-03-31 | |
| 03701505801075 | PUREKIT Syringes | T060426 | 2025-03-31 | |
| 03701505801082 | Syringes 4cc | T060427 | 2025-03-31 | |
| 03701505801099 | Syringes 1.5cc | T060428 | 2025-03-31 | |
| 03760177045361 | PureKit Gun MV | T060425MV | 2023-03-30 | |
| 03760177040113 | OPACITY + | T040320Z | T040320Z | 2015-10-16 |
| 03760177041110 | F20 | T040520 | T040520 | 2015-10-16 |
| 03760177041721 | HIGH V+ | T040321 | T040321 | 2017-08-22 |
| 03760177042391 | EXOFIX | T040323 | T040323 | 2015-10-16 |
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