Primary Device ID | 10603295539643 |
NIH Device Record Key | 8cdfab54-279a-4979-945a-59e349b9bfc4 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | INHANCE |
Version Model Number | 6201-01-171 |
Catalog Number | 620101171 |
Company DUNS | 989365556 |
Company Name | DEPUY (IRELAND) |
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 | 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 | false |
OTC Over-The-Counter | false |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx |
Device Issuing Agency | Device ID |
---|---|
GS1 | 10603295539643 [Primary] |
LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
Steralize Prior To Use | true |
Device Is Sterile | false |
[10603295539643]
Moist Heat or Steam Sterilization
[10603295539643]
Moist Heat or Steam Sterilization
[10603295539643]
Moist Heat or Steam Sterilization
[10603295539643]
Moist Heat or Steam Sterilization
[10603295539643]
Moist Heat or Steam Sterilization
[10603295539643]
Moist Heat or Steam Sterilization
[10603295539643]
Moist Heat or Steam Sterilization
[10603295539643]
Moist Heat or Steam Sterilization
[10603295539643]
Moist Heat or Steam Sterilization
[10603295539643]
Moist Heat or Steam Sterilization
[10603295539643]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2021-09-07 |
Device Publish Date | 2021-08-30 |
10603295546146 | INHANCE SHOULDER SYSTEM TRIAL INSTRUMENT CASE COMPLETE |
10603295546139 | INHANCE SHOULDER SYSTEM GENERAL INSTRUMENT CASE COMPLETE |
10603295546122 | INHANCE SHOULDER SYSTEM CIRCULAR GLENOID REAMER CADDY COMPLETE |
10603295546115 | INHANCE SHOULDER SYSTEM BOWTIE GLENOID REAMER CADDY COMPLETE |
10603295539650 | INHANCE SHOULDER SYSTEM SHARK FIN OSTEOTOME |
10603295539643 | INHANCE SHOULDER SYSTEM HEAD DISTRACTOR |
10603295539513 | INHANCE SHOULDER SYSTEM GLENOID REAMER - BOWTIE X-LARGE |
10603295539506 | INHANCE SHOULDER SYSTEM GLENOID REAMER - BOWTIE LARGE |
10603295539490 | INHANCE SHOULDER SYSTEM GLENOID REAMER - BOWTIE MEDIUM |
10603295539483 | INHANCE SHOULDER SYSTEM GLENOID REAMER - BOWTIE SMALL |
10603295539476 | INHANCE SHOULDER SYSTEM GLENOID REAMER - BOWTIE X-SMALL |
10603295539445 | INHANCE SHOULDER SYSTEM TAPER AND SHELL EXTRACTOR TIP |
10603295539438 | INHANCE SHOULDER SYSTEM DRIVER HANDLE |
10603295539421 | INHANCE SHOULDER SYSTEM DRIVER |
10603295539414 | INHANCE SHOULDER SYSTEM CONVEX IMPACTOR TIP |
10603295539407 | INHANCE SHOULDER SYSTEM CONCAVE IMPACTOR TIP |
10603295539391 | INHANCE SHOULDER SYSTEM STAR DRIVER 30 |
10603295539384 | INHANCE SHOULDER SYSTEM IMPACTOR HANDLE |
10603295539377 | INHANCE SHOULDER SYSTEM HUMERAL PIN GUIDE |
10603295539360 | INHANCE SHOULDER SYSTEM TRIAL HUMERAL HEAD OFFSET TAPER ADAPTER |
10603295539353 | INHANCE SHOULDER SYSTEM STEM INSERTER BOLT |
10603295539346 | INHANCE SHOULDER SYSTEM STEM INSERTER |
10603295539339 | INHANCE SHOULDER SYSTEM CANNULATED IMPACTOR HANDLE |
10603295539322 | INHANCE SHOULDER SYSTEM HUMERAL STEM PATHFINDER |
10603295539315 | INHANCE SHOULDER SYSTEM HUMERAL STEM PIN PUNCH |
10603295539308 | INHANCE SHOULDER SYSTEM HUMERAL HEAD TRIAL diameter 57mm X 24mm |
10603295539292 | INHANCE SHOULDER SYSTEM HUMERAL HEAD TRIAL diameter 57mm X 20.5mm |
10603295539285 | INHANCE SHOULDER SYSTEM HUMERAL HEAD TRIAL diameter 54mm X 22mm |
10603295539278 | INHANCE SHOULDER SYSTEM HUMERAL HEAD TRIAL diameter 54mm X 19mm |
10603295539261 | INHANCE SHOULDER SYSTEM HUMERAL HEAD TRIAL diameter 51mm X 20.5mm |
10603295539254 | INHANCE SHOULDER SYSTEM HUMERAL HEAD TRIAL diameter 51mm X 18mm |
10603295539247 | INHANCE SHOULDER SYSTEM HUMERAL HEAD TRIAL diameter 48.5mm X 19.5mm |
10603295539230 | INHANCE SHOULDER SYSTEM HUMERAL HEAD TRIAL diameter 48.5mm X 17mm |
10603295539223 | INHANCE SHOULDER SYSTEM HUMERAL HEAD TRIAL diameter 46mm X 18.5mm |
10603295539216 | INHANCE SHOULDER SYSTEM HUMERAL HEAD TRIAL diameter 46mm X 16mm |
10603295539209 | INHANCE SHOULDER SYSTEM HUMERAL HEAD TRIAL diameter 44mm X 17.25mm |
10603295539193 | INHANCE SHOULDER SYSTEM HUMERAL HEAD TRIAL diameter 44mm X 15.25mm |
10603295539186 | INHANCE SHOULDER SYSTEM HUMERAL HEAD TRIAL diameter 42mm X 16.5mm |
10603295539179 | INHANCE SHOULDER SYSTEM HUMERAL HEAD TRIAL diameter 42mm X 14.5mm |
10603295539162 | INHANCE SHOULDER SYSTEM HUMERAL HEAD TRIAL diameter 40mm X 15.75mm |
10603295539155 | INHANCE SHOULDER SYSTEM HUMERAL HEAD TRIAL diameter 40mm X 13.75mm |
10603295539148 | INHANCE SHOULDER SYSTEM HUMERAL HEAD TRIAL diameter 38mm X 13.5mm |
10603295539131 | INHANCE SHOULDER SYSTEM HUMERAL SIZER X-LARGE diameter 44mm |
10603295539124 | INHANCE SHOULDER SYSTEM HUMERAL SIZER LARGE diameter 40mm |
10603295539117 | INHANCE SHOULDER SYSTEM HUMERAL SIZER MEDIUM diameter 36mm |
10603295539100 | INHANCE SHOULDER SYSTEM HUMERAL SIZER SMALL diameter 32mm |
10603295539094 | INHANCE SHOULDER SYSTEM HUMERAL SIZER X-SMALL diameter 28mm |
10603295539087 | INHANCE SHOULDER SYSTEM HUMERAL BLAZER X-LARGE diameter 44mm |
10603295539070 | INHANCE SHOULDER SYSTEM HUMERAL BLAZER LARGE diameter 40mm |
10603295539063 | INHANCE SHOULDER SYSTEM HUMERAL BLAZER MEDIUM diameter 36mm |