Primary Device ID | 00846468074326 |
NIH Device Record Key | e87b04ac-0b3f-4ca3-ba12-c82506accb6a |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Zimmer Cannulated Screw System |
Version Model Number | 00-1147-068-00 |
Catalog Number | 00-1147-068-00 |
Company DUNS | 793384496 |
Company Name | Pioneer Surgical Technology, Inc. |
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 | true |
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 |
Phone | +1(386)418-8888 |
labeling@rtix.com | |
Phone | +1(386)418-8888 |
labeling@rtix.com | |
Phone | +1(386)418-8888 |
labeling@rtix.com | |
Phone | +1(386)418-8888 |
labeling@rtix.com | |
Phone | +1(386)418-8888 |
labeling@rtix.com | |
Phone | +1(386)418-8888 |
labeling@rtix.com | |
Phone | +1(386)418-8888 |
labeling@rtix.com | |
Phone | +1(386)418-8888 |
labeling@rtix.com | |
Phone | +1(386)418-8888 |
labeling@rtix.com | |
Phone | +1(386)418-8888 |
labeling@rtix.com | |
Phone | +1(386)418-8888 |
labeling@rtix.com | |
Phone | +1(386)418-8888 |
labeling@rtix.com | |
Phone | +1(386)418-8888 |
labeling@rtix.com | |
Phone | +1(386)418-8888 |
labeling@rtix.com | |
Phone | +1(386)418-8888 |
labeling@rtix.com | |
Phone | +1(386)418-8888 |
labeling@rtix.com | |
Phone | +1(386)418-8888 |
labeling@rtix.com | |
Phone | +1(386)418-8888 |
labeling@rtix.com | |
Phone | +1(386)418-8888 |
labeling@rtix.com | |
Phone | +1(386)418-8888 |
labeling@rtix.com | |
Phone | +1(386)418-8888 |
labeling@rtix.com | |
Phone | +1(386)418-8888 |
labeling@rtix.com | |
Phone | +1(386)418-8888 |
labeling@rtix.com | |
Phone | +1(386)418-8888 |
labeling@rtix.com | |
Phone | +1(386)418-8888 |
labeling@rtix.com | |
Phone | +1(386)418-8888 |
labeling@rtix.com | |
Phone | +1(386)418-8888 |
labeling@rtix.com | |
Phone | +1(386)418-8888 |
labeling@rtix.com | |
Phone | +1(386)418-8888 |
labeling@rtix.com | |
Phone | +1(386)418-8888 |
labeling@rtix.com | |
Phone | +1(386)418-8888 |
labeling@rtix.com | |
Phone | +1(386)418-8888 |
labeling@rtix.com | |
Phone | +1(386)418-8888 |
labeling@rtix.com | |
Phone | +1(386)418-8888 |
labeling@rtix.com | |
Phone | +1(386)418-8888 |
labeling@rtix.com | |
Phone | +1(386)418-8888 |
labeling@rtix.com | |
Phone | +1(386)418-8888 |
labeling@rtix.com | |
Phone | +1(386)418-8888 |
labeling@rtix.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00846468074326 [Primary] |
HWJ | AWL |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00846468074326]
Moist Heat or Steam Sterilization
[00846468074326]
Moist Heat or Steam Sterilization
[00846468074326]
Moist Heat or Steam Sterilization
[00846468074326]
Moist Heat or Steam Sterilization
[00846468074326]
Moist Heat or Steam Sterilization
[00846468074326]
Moist Heat or Steam Sterilization
[00846468074326]
Moist Heat or Steam Sterilization
[00846468074326]
Moist Heat or Steam Sterilization
[00846468074326]
Moist Heat or Steam Sterilization
[00846468074326]
Moist Heat or Steam Sterilization
[00846468074326]
Moist Heat or Steam Sterilization
[00846468074326]
Moist Heat or Steam Sterilization
[00846468074326]
Moist Heat or Steam Sterilization
[00846468074326]
Moist Heat or Steam Sterilization
[00846468074326]
Moist Heat or Steam Sterilization
[00846468074326]
Moist Heat or Steam Sterilization
[00846468074326]
Moist Heat or Steam Sterilization
[00846468074326]
Moist Heat or Steam Sterilization
[00846468074326]
Moist Heat or Steam Sterilization
[00846468074326]
Moist Heat or Steam Sterilization
[00846468074326]
Moist Heat or Steam Sterilization
[00846468074326]
Moist Heat or Steam Sterilization
[00846468074326]
Moist Heat or Steam Sterilization
[00846468074326]
Moist Heat or Steam Sterilization
[00846468074326]
Moist Heat or Steam Sterilization
[00846468074326]
Moist Heat or Steam Sterilization
[00846468074326]
Moist Heat or Steam Sterilization
[00846468074326]
Moist Heat or Steam Sterilization
[00846468074326]
Moist Heat or Steam Sterilization
[00846468074326]
Moist Heat or Steam Sterilization
[00846468074326]
Moist Heat or Steam Sterilization
[00846468074326]
Moist Heat or Steam Sterilization
[00846468074326]
Moist Heat or Steam Sterilization
[00846468074326]
Moist Heat or Steam Sterilization
[00846468074326]
Moist Heat or Steam Sterilization
[00846468074326]
Moist Heat or Steam Sterilization
[00846468074326]
Moist Heat or Steam Sterilization
[00846468074326]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2020-10-05 |
Device Publish Date | 2020-09-25 |
00846468074739 | LONG LENGTH BIT NOSE ATTACHMENT |
00846468074722 | STANDARD BIT NOSE ATTACHMENT |
00846468074715 | TENSIONER BIT LEVER ARM ATTACHMENT |
00846468074708 | LONG TENSIONER BIT |
00846468074692 | STANDARD TENSIONER BIT |
00846468074685 | CABLE TENSIONER |
00846468074678 | DEPTH GAUGE, 3.2mm X 300mm GUIDE WIRE |
00846468074661 | GUIDE PIN, 3.2mm X 295 mm SMOOTH SHAFT DRILL POINT |
00846468074654 | GUIDE PIN, 3.2mm X 295mm SMOOTH SHAFT TROC TIP |
00846468074647 | GUIDE PIN, 3.2mm X 295 mm PART THREAD TROCAR TIP |
00846468074630 | GUIDE PIN, 1.6mm X 150mm SMOOTH SHAFT TROC TIP |
00846468074623 | GUIDE PIN, 3.2mm X 225 mm SMOOTH SHAFT DRILL POINT |
00846468074616 | GUIDE PIN, 3.2mm X 225mm SMOOTH SHAFT TROC TIP |
00846468074609 | GUIDE PIN, 2.4mm X 224mm SMOOTH SHAFT TROC TIP |
00846468074593 | GUIDE PIN, 1.6mm X 226mm SMOOTH SHAFT TROC TIP |
00846468074586 | GUIDE PIN, 1.25mm X 150mm SMOOTH SHAFT TROC TIP |
00846468074579 | GUIDE PIN, 3.2mm X 225 mm PART THREAD TROCAR TIP |
00846468074562 | GUIDE PIN, 2.4mm X 224mm PART THREAD TROCAR TIP |
00846468074555 | GUIDE PIN, 1.6mm X 226 mm PART THREAD TROC TIP |
00846468074548 | GUIDE PIN, 1.25mm X 150mm PART THREAD TROCAR TIP |
00846468074531 | GUIDE PIN, 1.6mm X 150mm PART THREAD TROCAR TIP |
00846468074524 | T-HANDLE EZ OUT (4.5mm, 5.5mm, 6.5mm, 7.0mm, 7.5mm SCREWS) |
00846468074517 | T-HANDLE EZ OUT (3.0mm, 3.5mm, 4.0mm SCREWS) |
00846468074500 | SCREW HOLDING SLEEVE, 6.5mm/7.0mm/7.5mm |
00846468074494 | SCREW HOLDING SLEEVE, 4.5mm/5.5mm |
00846468074487 | SCREW HOLDING SLEEVE, 3.0mm |
00846468074470 | SCREW HOLDING SLEEVE, 3.5mm/4.0mm |
00846468074463 | SCREW FORCEPS |
00846468074456 | CLEANING BRUSH, 3.2mm |
00846468074449 | 7.5MM CANNULATED SCREW CASE BASE |
00846468074432 | CLEANING BRUSH, 2.4mm |
00846468074425 | 7.0MM CANNULATED SCREW TRAY |
00846468074418 | CLEANING BRUSH, 1.6mm |
00846468074401 | STERILIZATION CASE, 7.5mm |
00846468074395 | CLEANING BRUSH, 1.25mm |
00846468074388 | STYLET, 3.2mm |
00846468074371 | STYLET, 2.4mm |
00846468074364 | STYLET, 1.6mm |
00846468074357 | Sterilization Case, Top Tray, 7.0 mm |
00846468074340 | STERILIZATION CASE, 7.0mm |
00846468074333 | STYLET, 1.25mm |
00846468074326 | TROCAR, 3.2mm |
00846468074319 | TROCAR, 2.4mm |
00846468074302 | TROCAR, 1.6mm |
00846468074296 | STERILIZATION CASE, 6.5mm |
00846468074289 | TROCAR, 1.25mm |
00846468074272 | CANNULATED HEXAGONAL DRIVER, 2.5mm |
00846468074265 | PARALLEL PIN GUIDE, 3.2mm |
00846468074258 | ADJUSTABLE PARALLEL PIN GUIDE, 3.2mm |
00846468074241 | ADJUSTABLE PARALLEL PIN GUIDE, 2.4mm |