| Primary Device ID | 06970469419993 |
| NIH Device Record Key | 6d6ac017-8a14-4e04-9bc5-88caf9d6cc8c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | KLO Metal Self-ligating Door Opening Tool |
| Version Model Number | KLO-001 |
| Company DUNS | 412892520 |
| Company Name | Zhejiang Headway Medical Equipment Co., Ltd |
| 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 | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06970469419269 [Direct Marking] |
| GS1 | 06970469419993 [Primary] |
| DZN | Instruments, Dental Hand |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[06970469419993]
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[06970469419993]
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[06970469419993]
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[06970469419993]
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[06970469419993]
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[06970469419993]
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[06970469419993]
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[06970469419993]
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[06970469419993]
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[06970469419993]
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[06970469419993]
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| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-12-04 |
| Device Publish Date | 2025-11-26 |
| 06970469418514 - 02X KLO Metal Self-Ligating +5.2 | 2025-12-04 PK OF 5 |
| 06970469418521 - 03X KLO Metal Self-Ligating +5.4 | 2025-12-04 PK OF 5 |
| 06970469418538 - 04X KLO Metal Self-Ligating +15.0 | 2025-12-04 PK OF 5 |
| 06970469418545 - 05X KLO Metal Self-Ligating +15.2 | 2025-12-04 PK OF 5 |
| 06970469418552 - 06X KLO Metal Self-Ligating +15.4 | 2025-12-04 PK OF 5 |
| 06970469418569 - 07X KLO Metal Self-Ligating -5.0 | 2025-12-04 PK OF 5 |
| 06970469418576 - 08X KLO Metal Self-Ligating -5.2 | 2025-12-04 PK OF 5 |
| 06970469418583 - 09X KLO Metal Self-Ligating -5.4 | 2025-12-04 PK OF 5 |