| Primary Device ID | 20613994327998 |
| NIH Device Record Key | 1eabd4b9-2b05-4453-8f80-6d31eb53040f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | N/A |
| Version Model Number | 945DME1001 |
| Company DUNS | 835465063 |
| Company Name | MEDTRONIC XOMED, INC. |
| Device Count | 24 |
| 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(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00613994327994 [Unit of Use] |
| GS1 | 20613994327998 [Primary] |
| GXZ | ELECTRODE, NEEDLE |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[20613994327998]
Moist Heat or Steam Sterilization
[20613994327998]
Moist Heat or Steam Sterilization
[20613994327998]
Moist Heat or Steam Sterilization
[20613994327998]
Moist Heat or Steam Sterilization
[20613994327998]
Moist Heat or Steam Sterilization
[20613994327998]
Moist Heat or Steam Sterilization
[20613994327998]
Moist Heat or Steam Sterilization
[20613994327998]
Moist Heat or Steam Sterilization
[20613994327998]
Moist Heat or Steam Sterilization
[20613994327998]
Moist Heat or Steam Sterilization
[20613994327998]
Moist Heat or Steam Sterilization
[20613994327998]
Moist Heat or Steam Sterilization
[20613994327998]
Moist Heat or Steam Sterilization
[20613994327998]
Moist Heat or Steam Sterilization
[20613994327998]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-07-01 |
| 20613994839637 | INSTRUMENT WIPE 2218525 25PK 9CM X 9CM |
| 00613994513953 | PROBE 945CNP2002 100MM CONCENTRIC |
| 00613994370075 | BUR 31113065 3MM CRS DIAMOND MED LENGTH |
| 00613994370068 | BUR 31112565 2.5MM CRS DIAMD MED LENGTH |
| 00613994370051 | BUR 31112065 2MM CRS DIAMOND MED LENGTH |
| 00613994370020 | BUR 31133065 3MM FINE DIAMOND MED LENGTH |
| 00613994370013 | BUR 31132565 2.5MM FINE DIAMD MED LENGTH |
| 00613994370006 | BUR 31132065 2MM FINE DIAMD MED LENGTH |
| 00613994369994 | BUR 31131565 1.5MM FINE DIAMD MED LENGTH |
| 00613994369987 | BUR 31131066 1MM FINE DIAMD MED LENGTH |
| 00613994369970 | BUR 31130566 .5MM FINE DIAMD MED LENGTH |
| 00613994369963 | BUR 31313065UE ULTRA 3MM STEEL MED LGTH |
| 00613994369956 | BUR 31312565UE ULTRA 2.5MM STL MED LGTH |
| 00613994369949 | BUR 31312065 2MM STEEL MED LENGTH |
| 00613994369932 | BUR 31311565 1.5MM STEEL MED LENGTH |
| 00613994369925 | BUR 31311066 1MM STEEL MED LENGTH |
| 00613994353184 | BUR 31133565 3.5MM FINE DIAMD MED LENGTH |
| 00613994353122 | BUR 31113565 3.5MM CRS DIAMD MED LENGTH |
| 00613994353023 | BUR 31313565UE ULTRA 3.5MM STEEL MED L |
| 00613994353016 | BUR 31311075 1MM STEEL X-LONG |
| 00613994353009 | BUR 31311575 1.5MM STEEL X-LONG |
| 00613994352996 | BUR 31312075 2MM STEEL X-LONG |
| 00613994352989 | BUR 31312575 2.5MM STEEL X-LONG |
| 00613994352972 | BUR 31313075UE ULTRA 3MM STEEL X-LONG |
| 00613994352965 | BUR 31313575UE ULTRA 3.5MM STEEL X-LONG |
| 00613994352958 | BUR 31314075UE ULTRA 4MM STEEL X-LONG |
| 20613994233329 | BLADE 1884080HR 5PK TRICUT M4 13CM 4MM |
| 00613994233233 | BUR 1885078HSE 13CM X 5MM 70DEG DIAMOND |
| 00613994233219 | BUR 1883277HSE 15CM X 3.2MM 40DG DIAMOND |
| 00613994233196 | BUR 1885076HSE 15CM X 5MM 15DEG DIAMOND |
| 00613994233189 | BUR 1884075HSE 15CM X 4MM 15DEG CUTTING |
| 00613994233165 | BUR 1883274HSE 15CM X 3.2MM 15DG DIAMOND |
| 00613994221476 | BUR 31236058 6MM SST PEAR MED LENGTH |
| 00613994221469 | BUR 31255558 5.5MM SST OVAL MED LENGTH |
| 00613994221421 | BUR 31134065 4MM FINE DIAMOND MED LENGTH |
| 00613994221414 | BUR 31135059 5MM FINE DIAMOND MED LENGTH |
| 00613994221407 | BUR 31136058 6MM FINE DIAMOND MED LENGTH |
| 00613994221391 | BUR 31114065 4MM CRSE DIAMOND MED LENGTH |
| 00613994221377 | BUR 31115059 5MM CRSE DIAMOND MED LENGTH |
| 00613994221360 | BUR 31116058 6MM CRSE DIAMOND MED LENGTH |
| 00613994102232 | BUR 31314065UE ULTRA 4MM MED LENGTH |
| 20613994102229 | BUR 31314065U ULTRA 5PK 4MM MED LENGTH |
| 00613994102218 | BUR 31315059UE ULTRA 5MM MED LENGTH |
| 20613994102205 | BUR 31315059U ULTRA 5PK 5MM MED LENGTH |
| 00613994102188 | BUR 31316058UE ULTRA 6MM MED LENGTH |
| 20613994102175 | BUR 31316058U ULTRA 5PK 6MM MED LENGTH |
| 00613994102164 | BUR 31317057UE ULTRA 7MM MED LENGTH |
| 20613994102151 | BUR 31317057U ULTRA 5PK 7MM MED LENGTH |
| 00613994097170 | BUR 31135051 5MM FINE DIAMOND STD LENGTH |
| 00643169938847 | ELECTRODE 8227703 PRD NDL 22MM 8CH ROHS |