| Primary Device ID | 00614950025442 |
| NIH Device Record Key | 521d968a-8e23-48dc-9ba2-6b1b7ecedecf |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ACE |
| Version Model Number | 02411014 |
| Catalog Number | 02411014 |
| Company DUNS | 042763706 |
| Company Name | ACE SURGICAL SUPPLY CO., 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 | true |
| 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 |
| Phone | +1(508)588-3100 |
| ritaknight@acesurgical.com | |
| Phone | +1(508)588-3100 |
| ritaknight@acesurgical.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00614950025442 [Primary] |
| DZE | IMPLANT, ENDOSSEOUS, ROOT-FORM |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00614950025442]
Radiation Sterilization
[00614950025442]
Radiation Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-07-12 |
| Device Publish Date | 2018-06-11 |
| 00614950025442 | REPLACEMENT ORINGS F/miniMARK BALL ABUTMENT KEEPER 5/PKG |
| 00614950011438 | ACE INFUSER BAG ONLY |
| 00614950011421 | PRESSURE INFUSER BAG F/ 500 & 1000ML SOL COMP/GAUGE & BULB |
| 10614950009159 | ADMIN SET IV 68" CONVERT PIN W/FLASH BULB 15DPS/MIN 50/CA |
| 10614950008848 | ACE EXTENSION TUBE 30" W/L MEDSITE STER 4CC VOL 100/CA |
| 10614950008831 | ACE EXTENSION TUBE 20" W/L MEDSITE STER 3CC VOL 100/CA |
| 10614950008824 | ACE EXTENSION TUBE 12" W/L MEDSITE STER 2CC VOL 100/CA |
| 10614950008817 | ACE EXTENSION TUBE 30" STER 4CC VOLUME L/F 100/CA |
| 10614950008800 | ACE EXTENSION TUBE 20" STER 3CC VOLUME L/F 100/CA |
| 10614950008794 | ACE EXTENSION TUBE 12" STER 2CC VOLUME L/F 100/CA |
| 10614950008763 | ELECTRODE CLOTH ROUND 2" DIA 3/STRIP 10STRIPS/BAG |
| 10614950008756 | ELECTRODE FOAM ROUND 2" DIA 30/BAG L/F |
| 10614950008749 | ELECTRODE FOAM ROUND 2" DIA. 3/STRIP 10STRIPS/BAG 30/BAG |
| 10614950008527 | MASK FACE EAR LOOP BLUE 50/BOX L/F |
| 00614950008510 | Mask Cone Face Pink Fluid Resistant RESISTANT 50/BX W/L |
| 00614950008503 | Mask Cone Type Blue Fluid Resistant RESISTANT 50/BX W/L |
| 00614950008490 | Titanium Single Butterfly Mesh, 30x80mm, 0.25mm thick |
| 00614950008483 | Titanium Custom Tenting Mesh, 15x30mm, 0.25mm Thick |
| 00614950008476 | Titanium Tenting Mesh, 15x30mm, 0.25mm Thick |
| 00614950008094 | Orthodontic Skeletal Anchorage Kit |
| 00614950007080 | ABUTMENT REPLICA BRASS |
| 10614950007056 | SANI SLEEVE 2X60" STER 10/PKG L/F |
| 00614950003686 | GOLD CASTING SHEATH F/UNIV STD ABUT 7.5CW |
| 00614950003655 | WAXING SCREW HX FOR GOLD ABUTMENT F/4&5 SYSTEMS (TI6AL4VELI) |
| 00614950003648 | * WAXING SCREW F/GOLD CYLINDER F/3.5HD IMPLANT (TI6AL4VELI) |
| 00614950003631 | * UNIV STD ABUT POLISH PROT 7.5CW |
| 00614950003624 | * UNIV STD ABUT 7CW POLISH PROTECTOR |
| 00614950003617 | * UNIV STD ABUT 6.5CW POLISH PROTECTOR 5HD |
| 00614950003600 | * UNIV STD ABUT 5.5CW POLISH PROTECTOR 4&5HD |
| 00614950003594 | * UNIV STD ABUT 4.5CW POLISH PROTECTOR 4HD |
| 00614950002740 | 4.75X11.5MM SDS XHEX IMPLANT |
| 00614950002726 | HA PM 5.75X11.5 SELF TAP TAPER IMPLANT 6HD VARIABLE HEX MOUNT |
| 00614950002719 | HA PM 5.75X10 SELF TAP TAPERED IMPLANT 6HD VARIABLE HEX MOUNT |
| 00614950002702 | HA PM 4.75X13 SELF TAP TAPERED IMPLANT 5HD VARIABLE HEX MOUNT |
| 00614950002696 | HA PM 4X11.5 SELF TAP TAPERED IMPLANT 4HD VARIABLE HEX MOUNT |
| 00614950002689 | HA PM 4X13 SELF TAP TAPERED IMPLANT 4HD VARIABLE HEX MOUNT |
| 00614950002672 | HA PM 3.75X13 SELF TAP TAPERED IMPLANT 4HD VARIABLE HEX MOUNT |
| 00614950002665 | HA PM 3.75X10 SELF TAP TAPERED IMPLANT 4HD VARIABLE HEX MOUNT |
| 00614950002658 | HA PM 3.75X8 SELF TAP TAPERED IMPLANT 4HD VARIABLE HEX MOUNT |
| 00614950002641 | 5.75X11.5 RBM PM 6HD SELF TAP IMPLANT W/HEX MOUNT |
| 00614950002634 | 5.75X10 RBM PM 6HD SELF TAP IMPLANT W/HEX MOUNT |
| 00614950002627 | 5.75X8 RBM PM 6HD SELF TAP IMPLANT W/HEX MOUNT |
| 00614950002610 | 4.75x11.5 RBM PM 5HD TAPER SELF TAP IMPLANT W/HEX MOUNT VARIABLE |
| 00614950002603 | 4.75X13 RBM PM 5HD TAPER SELF TAP IMPLANT W/HEX MOUNT TWO THREADS DOWN |
| 00614950002597 | 4X11.5 RBM PM 4HD TAPERED SELF TAP IMPLANT W/HEXAGON MOUNT rbm two threads down |
| 00614950002580 | 4X11.5MM XHEX IMPLANT (CPTIGR4) SPECIAL ORDER |
| 00614950002573 | 4X15MM XHEX IMPLANT (CPTIGR4) SPECIAL ORDER |
| 00614950002566 | 4X13 RBM PM 4HD TAPERED SELF TAP IMPLANT W/HEXAGON MOUNT RBM IS TWO THREADS DOWN |
| 00614950002559 | 4X13MM XHEX IMPLANT (CPTIGR4) SPECIAL ORDER |
| 00614950002542 | 4X10 RBM PM 4HD TAPERED SELF TAP IMPLANT W/ HEXAGON MOUNT RMB'D TWO THREADS DOWN |