Primary Device ID | 10841291105817 |
NIH Device Record Key | e838da52-651d-4904-a036-2b923963c7fb |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Sternal Cable System |
Version Model Number | 400-410 |
Company DUNS | 173770868 |
Company Name | A & E MEDICAL CORPORATION |
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 | true |
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 | 10841291105817 [Primary] |
HTZ | Instrument, Cutting, Orthopedic |
Steralize Prior To Use | true |
Device Is Sterile | false |
[10841291105817]
Moist Heat or Steam Sterilization
[10841291105817]
Moist Heat or Steam Sterilization
[10841291105817]
Moist Heat or Steam Sterilization
[10841291105817]
Moist Heat or Steam Sterilization
[10841291105817]
Moist Heat or Steam Sterilization
[10841291105817]
Moist Heat or Steam Sterilization
[10841291105817]
Moist Heat or Steam Sterilization
[10841291105817]
Moist Heat or Steam Sterilization
[10841291105817]
Moist Heat or Steam Sterilization
[10841291105817]
Moist Heat or Steam Sterilization
[10841291105817]
Moist Heat or Steam Sterilization
[10841291105817]
Moist Heat or Steam Sterilization
[10841291105817]
Moist Heat or Steam Sterilization
[10841291105817]
Moist Heat or Steam Sterilization
[10841291105817]
Moist Heat or Steam Sterilization
[10841291105817]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2025-04-29 |
Device Publish Date | 2025-04-21 |
10841291106081 | INSTRUMENT CASE |
10841291106043 | Ti TWO PACK STERNAL CRIMPS |
10841291106036 | Ti TAPERED BLUNT NEEDLE, 4 CABLES PER POUCH |
10841291106029 | Ti REVERSE CUTTING NEEDLE, 4 CABLES PER POUCH |
10841291106012 | Ti 3 TAPERED BLUNT & 1 CUTTING EDGE NEEDLE, 4 CABLES PER POUCH |
10841291106005 | Ti TAPERED CUTTING NEEDLE, 4 CABLES PER POUCH |
10841291105992 | CRIMPER/TENSIONER |
10841291105978 | SS TAPERED BLUNT NEEDLE, 4 CABLES PER POUCH |
10841291105961 | SS 3 TAPERED BLUNT & 1 CUTTING EDGE NEEDLE, 4 CABLES PER POUCH |
10841291105954 | SS TAPERED BLUNT NEEDLE, 1 CABLE PER POUCH |
10841291105947 | Ti CUTTING EDGE NEEDLE, 4 CABLES PER POUCH |
10841291105930 | SS 3 TAPERED CUTTING & 1 REVERSE CUTTING NEEDLE, 4 CABLES PER POUCH |
10841291105923 | SS REVERSE CUTTING NEEDLE, 3 CABLES PER POUCH |
10841291105916 | SS CUTTING EDGE NEEDLE, 1 CABLE PER POUCH |
10841291105909 | SS CUTTING EDGE NEEDLE, 3 CABLES PER POUCH |
10841291105893 | SS CUTTING EDGE NEEDLE, 4 CABLES PER POUCH |
10841291105862 | SS TAPERED CUTTING NEEDLE, 1 CABLE PER POUCH |
10841291105855 | SS TAPERED CUTTING NEEDLE, 4 CABLES PER POUCH |
10841291105831 | SS REVERSE CUTTING NEEDLE, 1 CABLE PER POUCH |
10841291105824 | SS REVERSE CUTTING NEEDLE, 4 CABLES PER POUCH |
10841291105817 | CABLE CUTTER |
10841291105794 | SS TWO PACK STERNAL CRIMPS |