Primary Device ID | 10885862553072 |
NIH Device Record Key | 3bcf5940-2cf6-4b48-9b93-7a5eb6665ca8 |
Commercial Distribution Status | In Commercial Distribution |
Version Model Number | 01-007-30-0000 |
Catalog Number | 01-007-30-0000 |
Company DUNS | 157565946 |
Company Name | Exactech, Inc. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
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 | 10885862553072 [Primary] |
LZO | Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented |
Steralize Prior To Use | true |
Device Is Sterile | false |
[10885862553072]
Moist Heat or Steam Sterilization
[10885862553072]
Moist Heat or Steam Sterilization
[10885862553072]
Moist Heat or Steam Sterilization
[10885862553072]
Moist Heat or Steam Sterilization
[10885862553072]
Moist Heat or Steam Sterilization
[10885862553072]
Moist Heat or Steam Sterilization
[10885862553072]
Moist Heat or Steam Sterilization
[10885862553072]
Moist Heat or Steam Sterilization
[10885862553072]
Moist Heat or Steam Sterilization
[10885862553072]
Moist Heat or Steam Sterilization
[10885862553072]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2022-08-05 |
Device Publish Date | 2022-07-28 |
10885862634108 - Equinoxe | 2024-07-16 Special Truliant Spike EM Tibial Guide |
10885862634115 - Equinoxe | 2024-07-16 Special Spiked Tibial Resector Extractor Hook |
10885862635044 - Equinoxe | 2024-07-16 Special Small Spiked Humeral Resection Cover |
10885862635051 - Equinoxe | 2024-07-16 Special Medium Spiked Humeral Resection Cover |
10885862635068 - Equinoxe | 2024-07-16 Special Large Spiked Humeral Resection Cover |
10885862635143 - Equinoxe | 2024-07-16 Special Laser Cage Trephine Drill. 0-8 Deg, Peripheral Pegs |
10885862635150 - Equinoxe | 2024-07-16 Special Laser Cage Trephone Drill. 0-8 Deg, Central Cage |
10885862630704 - Equinoxe | 2024-06-20 Special Modular rTSA 32mm Circular Reamer |