CRESCENT™ Spinal System
GUDID 00613994898081
TRAY 6660006 GEN INST LOWER
MEDTRONIC SOFAMOR DANEK, INC.
Instrument tray, reusable| Primary Device ID | 00613994898081 |
| NIH Device Record Key | 85e75c77-e403-41f6-ac8d-5342e3a77ea2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CRESCENT™ Spinal System |
| Version Model Number | 6660006 |
| Company DUNS | 830350380 |
| Company Name | MEDTRONIC SOFAMOR DANEK, 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 |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00613994898081 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K190840
FDA Product Code
| FSM | TRAY, SURGICAL, INSTRUMENT |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00613994898081]
Moist Heat or Steam Sterilization
[00613994898081]
Moist Heat or Steam Sterilization
[00613994898081]
Moist Heat or Steam Sterilization
[00613994898081]
Moist Heat or Steam Sterilization
[00613994898081]
Moist Heat or Steam Sterilization
[00613994898081]
Moist Heat or Steam Sterilization
[00613994898081]
Moist Heat or Steam Sterilization
[00613994898081]
Moist Heat or Steam Sterilization
[00613994898081]
Moist Heat or Steam Sterilization
[00613994898081]
Moist Heat or Steam Sterilization
[00613994898081]
Moist Heat or Steam Sterilization
[00613994898081]
Moist Heat or Steam Sterilization
[00613994898081]
Moist Heat or Steam Sterilization
[00613994898081]
Moist Heat or Steam Sterilization
[00613994898081]
Moist Heat or Steam Sterilization
[00613994898081]
Moist Heat or Steam Sterilization
[00613994898081]
Moist Heat or Steam Sterilization
[00613994898081]
Moist Heat or Steam Sterilization
[00613994898081]
Moist Heat or Steam Sterilization
[00613994898081]
Moist Heat or Steam Sterilization
[00613994898081]
Moist Heat or Steam Sterilization
[00613994898081]
Moist Heat or Steam Sterilization
[00613994898081]
Moist Heat or Steam Sterilization
[00613994898081]
Moist Heat or Steam Sterilization
[00613994898081]
Moist Heat or Steam Sterilization
[00613994898081]
Moist Heat or Steam Sterilization
[00613994898081]
Moist Heat or Steam Sterilization
[00613994898081]
Moist Heat or Steam Sterilization
[00613994898081]
Moist Heat or Steam Sterilization
[00613994898081]
Moist Heat or Steam Sterilization
[00613994898081]
Moist Heat or Steam Sterilization
[00613994898081]
Moist Heat or Steam Sterilization
[00613994898081]
Moist Heat or Steam Sterilization
[00613994898081]
Moist Heat or Steam Sterilization
[00613994898081]
Moist Heat or Steam Sterilization
[00613994898081]
Moist Heat or Steam Sterilization
[00613994898081]
Moist Heat or Steam Sterilization
[00613994898081]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-03-08 |
| Device Publish Date | 2021-02-28 |
On-Brand Devices [CRESCENT™ Spinal System]
| 00613994523518 | SPACER 6661636 CRESCENT TI |
| 00613994523501 | SPACER 6661630 CRESCENT TI |
| 00613994523495 | SPACER 6661625 CRESCENT TI |
| 00613994523419 | IMPACTOR 6661516 CRESCENT TI 15/16MM |
| 00613994523402 | IMPACTOR 6661314 CRESCENT TI 13/14MM |
| 00613994523396 | IMPACTOR 6661112 CRESCENT TI 11/12MM |
| 00613994523389 | IMPACTOR 6660910 CRESCENT TI 9/10MM |
| 00613994523372 | IMPACTOR 6660078 CRESCENT TI 7/8 MM |
| 00613994523365 | SPACER 6671230 CRESCENT TI |
| 00613994523358 | SPACER 6671236 CRESCENT TI |
| 00613994523341 | SPACER 6671330 CRESCENT TI |
| 00613994523334 | SPACER 6671336 CRESCENT TI |
| 00613994523327 | SPACER 6671430 CRESCENT TI |
| 00613994523310 | SPACER 6671436 CRESCENT TI |
| 00613994523303 | SPACER 6671530 CRESCENT TI |
| 00613994523297 | SPACER 6671536 CRESCENT TI |
| 00613994523280 | SPACER 6671630 CRESCENT TI |
| 00613994523273 | SPACER 6671636 CRESCENT TI |
| 00613994518026 | ASSEMBLY 7969210 L 42X30 10MM 12 DEG CP |
| 00613994518002 | SPACER 7969212 L 42 X 30 X 12MM 12 DEG |
| 00613994517982 | SPACER 7969214 L 42 X 30 X 14MM 12 DEG |
| 00613994517968 | ASSEMBLY 7969216 L 42X30 16MM 12 DEG CP |
| 00613994517951 | ASSEMBLY 7969218 L 42X30 18MM 12 DEG CP |
| 00613994517937 | SPACER 7969220 L 42 X 30 X 20MM 12 DEG |
| 00613994517913 | ASSEMBLY 7969222 L 42X30 22MM 12 DEG CP |
| 00613994517890 | ASSEMBLY 7969224 L 42X30 24MM 12 DEG CP |
| 00613994517883 | ASSEMBLY 7969810 L 42X30 10MM 8 DEG CP |
| 00613994517876 | SPACER 7969812 L 42 X 30 X 12MM 8 DEG |
| 00613994517869 | ASSEMBLY 7969814 L 42X30 14MM 8 DEG CP |
| 00613994517852 | SPACER 7969816 L 42 X 30 X 16MM 8 DEG |
| 00613994517845 | ASSEMBLY 7969818 L 42X30 18MM 8 DEG CP |
| 00613994517838 | ASSEMBLY 7969820 L 42X30 20MM 8 DEG CP |
| 00613994517821 | ASSEMBLY 7969822 L 42X30 22MM 8 DEG CP |
| 00613994517814 | SPACER 7969824 L 42 X 30 X 24MM 8 DEG |
| 00613994517807 | ASSEMBLY 7968210 M 37X27 10MM 12 DEG CP |
| 00613994517791 | ASSEMBLY 7968212 M 37X27 12MM 12 DEG CP |
| 00613994517784 | ASSEMBLY 7968214 M 37X27 14MM 12 DEG CP |
| 00613994517777 | ASSEMBLY 7968216 M 37X27 16MM 12 DEG CP |
| 00613994517760 | ASSEMBLY 7968218 M 37X27 18MM 12 DEG CP |
| 00613994517753 | ASSEMBLY 7968220 M 37X27 20MM 12 DEG CP |
| 00613994517746 | SPACER 7968222 M 37 X 27 X22MM 12 DEG |
| 00613994517739 | SPACER 7968224 M 37 X 27 X24MM 12 DEG |
| 00613994517722 | ASSEMBLY 7968810 M 37X27 10MM 8 DEG CP |
| 00613994517715 | ASSEMBLY 7968812 M 37X27 12MM 8 DEG CP |
| 00613994517708 | SPACER 7968814 M 37 X 27 X14MM 8 DEG |
| 00613994517692 | ASSEMBLY 7968816 M 37X27 16MM 8 DEG CP |
| 00613994517685 | ASSEMBLY 7968818 M 37X27 18MM 8 DEG CP |
| 00613994517678 | ASSEMBLY 7968820 M 37X27 20MM 8 DEG CP |
| 00613994517661 | ASSEMBLY 7968822 M 37X27 22MM 8 DEG CP |
| 00613994517654 | SPACER 7968824 M 37 X 27 X24MM, 8 DEG |
Trademark Results [CRESCENT]
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.