| Primary Device ID | 09421038411148 |
| NIH Device Record Key | 96a493ba-8c41-4b9c-9dd0-3f23a216f147 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Enztec Short SRD - Locking - Crossbar - Mini Zimmer |
| Version Model Number | 4250-7703 |
| Catalog Number | 4250-7703 |
| Company DUNS | 592616445 |
| Company Name | ENZTEC LIMITED |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 09421038411148 [Primary] |
| HWE | Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[09421038411148]
Moist Heat or Steam Sterilization
[09421038411148]
Moist Heat or Steam Sterilization
[09421038411148]
Moist Heat or Steam Sterilization
[09421038411148]
Moist Heat or Steam Sterilization
[09421038411148]
Moist Heat or Steam Sterilization
[09421038411148]
Moist Heat or Steam Sterilization
[09421038411148]
Moist Heat or Steam Sterilization
[09421038411148]
Moist Heat or Steam Sterilization
[09421038411148]
Moist Heat or Steam Sterilization
[09421038411148]
Moist Heat or Steam Sterilization
[09421038411148]
Moist Heat or Steam Sterilization
[09421038411148]
Moist Heat or Steam Sterilization
[09421038411148]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-07-29 |
| Device Publish Date | 2025-07-21 |
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| 09421028119061 - Base | 2025-10-06 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure |
| 09421028119078 - Head Holder | 2025-10-06 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure |
| 09421028119849 - Patella Drill Guide – Symbios XS-S-M | 2025-10-06 A reusable surgical instrument intended to be used during an orthopaedic surgical procedure |
| 09421028119856 - Patella Drill Guide – Symbios L - XL | 2025-10-06 A reusable surgical instrument intended to be used during an orthopaedic surgical procedure |
| 09421028119863 - Cement Clamp – Symbios XS-S | 2025-10-06 A reusable surgical instrument intended to be used during an orthopaedic surgical procedure |
| 09421028119870 - Cement Clamp – Symbios M-L-XL | 2025-10-06 A reusable surgical instrument intended to be used during an orthopaedic surgical procedure |
| 09421028119887 - Cement Clamp Pad – Symbios XS-S | 2025-10-06 A reusable surgical instrument intended to be used during an orthopaedic surgical procedure |