Integra® MicroFrance® CEV105P6
GUDID 10381780091561
SEALING CAP CEV105P6 6PK DIA 5MM
INTEGRA MICROFRANCE
Laparoscopic trocar blade, reusable| Primary Device ID | 10381780091561 |
| NIH Device Record Key | 00a7e546-9845-49dc-aef3-1f92ce2be2a5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Integra® MicroFrance® |
| Version Model Number | CEV105P6 |
| Catalog Number | CEV105P6 |
| Company DUNS | 276593071 |
| Company Name | INTEGRA MICROFRANCE |
| Device Count | 6 |
| 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 | 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 |
Customer Support Contacts
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry area |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry area |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry area |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry area |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry area |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry area |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry area |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry area |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry area |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry area |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry area |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry area |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry area |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry area |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry area |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry area |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry area |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry area |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry area |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry area |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry area |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry area |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry area |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry area |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry area |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry area |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry area |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry area |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry area |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry area |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00381780091564 [Unit of Use] |
| GS1 | 10381780091561 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K993653
FDA Product Code
| HET | LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES) |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10381780091561]
Moist Heat or Steam Sterilization
[10381780091561]
Moist Heat or Steam Sterilization
[10381780091561]
Moist Heat or Steam Sterilization
[10381780091561]
Moist Heat or Steam Sterilization
[10381780091561]
Moist Heat or Steam Sterilization
[10381780091561]
Moist Heat or Steam Sterilization
[10381780091561]
Moist Heat or Steam Sterilization
[10381780091561]
Moist Heat or Steam Sterilization
[10381780091561]
Moist Heat or Steam Sterilization
[10381780091561]
Moist Heat or Steam Sterilization
[10381780091561]
Moist Heat or Steam Sterilization
[10381780091561]
Moist Heat or Steam Sterilization
[10381780091561]
Moist Heat or Steam Sterilization
[10381780091561]
Moist Heat or Steam Sterilization
[10381780091561]
Moist Heat or Steam Sterilization
[10381780091561]
Moist Heat or Steam Sterilization
[10381780091561]
Moist Heat or Steam Sterilization
[10381780091561]
Moist Heat or Steam Sterilization
[10381780091561]
Moist Heat or Steam Sterilization
[10381780091561]
Moist Heat or Steam Sterilization
[10381780091561]
Moist Heat or Steam Sterilization
[10381780091561]
Moist Heat or Steam Sterilization
[10381780091561]
Moist Heat or Steam Sterilization
[10381780091561]
Moist Heat or Steam Sterilization
[10381780091561]
Moist Heat or Steam Sterilization
[10381780091561]
Moist Heat or Steam Sterilization
[10381780091561]
Moist Heat or Steam Sterilization
[10381780091561]
Moist Heat or Steam Sterilization
[10381780091561]
Moist Heat or Steam Sterilization
[10381780091561]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2022-10-26 |
| Device Publish Date | 2016-09-22 |
On-Brand Devices [Integra® MicroFrance®]
| 10381780091486 | HANDLE CEV103GH FOR 5MM SUCTION TUBE |
| 10381780091455 | HANDLE CEV103BG FOR 3.5 5MM SUCTION TUBE |
| 10381780091448 | HANDLE CEV103AH FOR 5/10MM SUCTION TUBE |
| 10381780091356 | SUCTION TUBE CEV103 DIA 5MM DIA 10MM |
| 10381780110958 | PICK MCO989 180MM CVD MONOPOLAR LEGENT |
| 10381780110552 | ELEVATOR MCO8BM 180MM MONOPOLAR BORDURE |
| 10381780108450 | BIPOLAR FORCEPS MCO291 95MM W/TRAY |
| 10381780108443 | BIPOLAR FORCEPS MCO290 70MM W/TRAY |
| 10381780107415 | BIPOLAR FORCEPS MCM6BIS 110MM STR |
| 10381780106777 | HOOK MCLP50 DIA 3MM MONOPOLAR HENRY |
| 10381780106760 | SCISSORS MCLP40 DIA 3MM CVD HENRY |
| 10381780106753 | FORCEPS MCLP30 DIA 3MM JAWS 8MM HENRY |
| 10381780106746 | FENESTRATED FORCEPS MCLP25 DIA 3MM HENRY |
| 10381780106739 | FENESTRATED FORCEPS MCLP20 DIA 3MM HENRY |
| 10381780106081 | FORCEPS MCL69 RT WARD BOUCHAYER CUP |
| 10381780106074 | FORCEPS MCL68 LFT WARD BOUCHAYER CUP |
| 10381780106067 | FORCEPS MCL67 UPWARD BOUCHAYER CUP |
| 10381780105985 | SUCTION TUBE MCL62 DIA 2.5MM 230MM |
| 10381780105978 | KNIFE MCL59 BAYONET MONOPOLAR FRECHE |
| 10381780105961 | INJECTION NEEDLE MCL58 BAYONET BOUCHAYER |
| 10381780105954 | KNIFE MCL57 220MM LANCET BOUCHAYER |
| 10381780105800 | INJECTION NEEDLE MCL55-1 240MM BAYONET |
| 10381780105794 | INSTRUMENT MCL55 PISTOL W/NEEDLE MCL55-1 |
| 10381780105565 | MICRO BIPOLAR FORCEPS MCL340 WL 210MM |
| 10381780105558 | BIPOLAR FORCEPS MCL34 290MM W/TRAY |
| 10381780105480 | SCISSORS MCL31 230MM ANG BOUCHAYER |
| 10381780105473 | FORCEPS MCL30 230MM RT BOUCHAYER CUP |
| 10381780105381 | FORCEPS MCL29 230MM LFT BOUCHAYER CUP |
| 10381780105350 | FORCEPS MCL241-1 LFT ABITBOL |
| 10381780105343 | FORCEPS MCL241 ALLIG CVD RT ABITBOL |
| 10381780105336 | FORCEPS MCL219-1 LEFT ABITBOL HEART |
| 10381780105329 | FORCEPS MCL219 RIGHT ABITBOL HEART |
| 10381780105312 | SUCTION TUBE MCL210 DIA 2.5MM ABITBOL |
| 10381780105213 | FORCEPS MCL205 230MM ABITBOL |
| 10381780105138 | FORCEPS MCL19 LEFT BOUCHAYER HEART |
| 10381780105121 | FORCEPS MCL18 ALLIG CVD RT BOUCHAYER |
| 10381780105077 | SCISSORS MCL17 230MM CVD LFT BOUCHAYER |
| 10381780105060 | SCISSORS MCL16 230MM CVD RT BOUCHAYER |
| 10381780105053 | FORCEPS MCL15 ALLIG LFT BOUCHAYER |
| 10381780104742 | SUCTION TUBE MCL10 230MM DIA 2.5MM |
| 10381780103646 | SUCTION TUBE MCEN730 130MM APPELBAUM |
| 10381780103479 | SUCTION TIP 5PK MCEN644 WORMALD |
| 10381780103462 | FORCEPS MCEN643 170MM UPCVD WORMALD BIPO |
| 10381780103455 | FORCEPS MCEN641 170MM WORMALD BIPOLAR |
| 10381780103431 | BIPOLAR FORCEPS MCEN64 120MM WORMALD |
| 10381780103264 | HANDLE MCEN54P DIA 5MM ANG BIPOLAR DESSI |
| 10381780103257 | BIPOLAR INSERT MCEN54I 120MM DESSI |
| 10381780103240 | BIPOLAR INSERT MCEN54H HERMAN |
| 10381780103233 | TUBE MCEN54G DIA 5MM 120MM DESSI |
| 10381780103226 | BIPOLAR FORCEPS MCEN54 120MM DESSI |
Trademark Results [Integra]
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