Primary Device ID | M97015000005120 |
NIH Device Record Key | abbd84f2-6036-4aec-84bf-24a29983cacc |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Eclipse |
Version Model Number | 1500-00-0512 |
Company DUNS | 601306413 |
Company Name | Medshape, Inc. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | MR Safe |
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 | true |
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 |
---|---|
HIBCC | M97015000005120 [Primary] |
MBI | Fastener, Fixation, Nondegradable, Soft Tissue |
Steralize Prior To Use | true |
Device Is Sterile | true |
[M97015000005120]
Ethylene Oxide
[M97015000005120]
Ethylene Oxide
[M97015000005120]
Ethylene Oxide
[M97015000005120]
Ethylene Oxide
[M97015000005120]
Ethylene Oxide
[M97015000005120]
Ethylene Oxide
[M97015000005120]
Ethylene Oxide
[M97015000005120]
Ethylene Oxide
[M97015000005120]
Ethylene Oxide
[M97015000005120]
Ethylene Oxide
[M97015000005120]
Ethylene Oxide
[M97015000005120]
Ethylene Oxide
[M97015000005120]
Ethylene Oxide
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 7 |
Public Version Date | 2025-07-17 |
Device Publish Date | 2017-05-19 |
M97015000200001 | Universal Tenodesis Disposable Procedure Pack |
M9701500020000 | Universal Tenodesis Disposable Procedure Pack |
M97023000109008 | Procedure Pack, 9.0MM Sterile Cannulated Drill/Reamer |
M9701500010900 | Procedure Pack, 9.0MM Sterile Cannulated Drill/Reamer |
M97023000108007 | Procedure Pack, 8.0MM Sterile Cannulated Drill/Reamer |
M9701500010800 | Procedure Pack, 8.0MM Sterile Cannulated Drill/Reamer |
M97023000107006 | Procedure Pack, 7.0MM Sterile Cannulated Drill/Reamer |
M9701500010700 | Procedure Pack, 7.0MM Sterile Cannulated Drill/Reamer |
M97023000106005 | Procedure Pack, 6.0MM Sterile Cannulated Drill/Reamer |
M9701500010600 | Procedure Pack, 6.0MM Sterile Cannulated Drill/Reamer |
M97023000105509 | Procedure Pack, 5.5MM Sterile Cannulated Drill/Reamer |
M9701500010550 | Procedure Pack, 5.5MM Sterile Cannulated Drill/Reamer |
M97023000105004 | Procedure Pack, 5.0MM Sterile Cannulated Drill/Reamer |
M9701500010500 | Procedure Pack, 5.0MM Sterile Cannulated Drill/Reamer |
M97023000204509 | Procedure Pack, 4.5MM Sterile Cannulated Drill/Reamer |
M9701500010450 | Procedure Pack, 4.5MM Sterile Cannulated Drill/Reamer |
M97015000104004 | Procedure Pack, 4MM Sterile Cannulated Drill/Reamer |
M9701500010400 | Procedure Pack, 4MM Sterile Cannulated Drill/Reamer |
M970150000092000 | ECLIPSE Soft Tissue Anchor, 9mm x 20mm |
M970150000091500 | ECLIPSE Soft Tissue Anchor, 9mm x 15mm |
M970150000082009 | ECLIPSE Soft Tissue Anchor, 8mm x 20mm |
M970150000081200 | ECLIPSE Soft Tissue Anchor, 8mm x 12mm |
M970150000072008 | ECLIPSE Soft Tissue Anchor, 7mm x 20mm |
M970150000071209 | ECLIPSE Soft Tissue Anchor, 7mm x 12mm |
M970150000062007 | ECLIPSE Soft Tissue Anchor, 6mm x 20mm |
M970150000061208 | ECLIPSE Soft Tissue Anchor, 6mm x 12mm |
M970150000052006 | ECLIPSE Soft Tissue Anchor, 5mm x 20mm |
M970150000051207 | ECLIPSE Soft Tissue Anchor, 5mm x 12mm |
M970150000041700 | ECLIPSE Soft Tissue Anchor, 4mm x 17mm |
M970150000041004 | ECLIPSE Soft Tissue Anchor, 4mm x 10mm |
M97015000008200 | ECLIPSE, 8MM X 20MM |
M97015000007200 | ECLIPSE, 7MM X 20MM |
M97015000006200 | ECLIPSE, 6MM X 20MM |
M97015000005200 | ECLIPSE, 5MM X 20MM |
M97015000005120 | ECLIPSE, 5MM X 12MM |
M97015000004170 | ECLIPSE, 4MM X 17MM |
M97015000004100 | ECLIPSE, 4MM X 10MM |