Integra® CEV605GPU
GUDID 10381780428473
Curved scissors insert, blades 15 mm, tube CEV8649GPU CEV649GPU CEV9649GPU and sheath CEV8649C5U CEV649C5U CEV9649C5U (pk3)
INTEGRA MICROFRANCE
Laparoscopic grasping forceps, reusable| Primary Device ID | 10381780428473 |
| NIH Device Record Key | 5d34a4f5-98bd-4a36-90b0-a783c435cd98 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Integra® |
| Version Model Number | CEV605GPU |
| Catalog Number | CEV605GPU |
| Company DUNS | 276593071 |
| Company Name | INTEGRA MICROFRANCE |
| Device Count | 3 |
| 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 | |
| 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 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00381780428476 [Unit of Use] |
| GS1 | 10381780428473 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K080257
FDA Product Code
| GCJ | Laparoscope, general & plastic surgery |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10381780428473]
Moist Heat or Steam Sterilization
[10381780428473]
Moist Heat or Steam Sterilization
[10381780428473]
Moist Heat or Steam Sterilization
[10381780428473]
Moist Heat or Steam Sterilization
[10381780428473]
Moist Heat or Steam Sterilization
[10381780428473]
Moist Heat or Steam Sterilization
[10381780428473]
Moist Heat or Steam Sterilization
[10381780428473]
Moist Heat or Steam Sterilization
[10381780428473]
Moist Heat or Steam Sterilization
[10381780428473]
Moist Heat or Steam Sterilization
[10381780428473]
Moist Heat or Steam Sterilization
[10381780428473]
Moist Heat or Steam Sterilization
[10381780428473]
Moist Heat or Steam Sterilization
[10381780428473]
Moist Heat or Steam Sterilization
[10381780428473]
Moist Heat or Steam Sterilization
[10381780428473]
Moist Heat or Steam Sterilization
[10381780428473]
Moist Heat or Steam Sterilization
[10381780428473]
Moist Heat or Steam Sterilization
[10381780428473]
Moist Heat or Steam Sterilization
[10381780428473]
Moist Heat or Steam Sterilization
[10381780428473]
Moist Heat or Steam Sterilization
[10381780428473]
Moist Heat or Steam Sterilization
[10381780428473]
Moist Heat or Steam Sterilization
[10381780428473]
Moist Heat or Steam Sterilization
[10381780428473]
Moist Heat or Steam Sterilization
[10381780428473]
Moist Heat or Steam Sterilization
[10381780428473]
Moist Heat or Steam Sterilization
[10381780428473]
Moist Heat or Steam Sterilization
[10381780428473]
Moist Heat or Steam Sterilization
[10381780428473]
Moist Heat or Steam Sterilization
[10381780428473]
Moist Heat or Steam Sterilization
[10381780428473]
Moist Heat or Steam Sterilization
[10381780428473]
Moist Heat or Steam Sterilization
[10381780428473]
Moist Heat or Steam Sterilization
[10381780428473]
Moist Heat or Steam Sterilization
[10381780428473]
Moist Heat or Steam Sterilization
[10381780428473]
Moist Heat or Steam Sterilization
[10381780428473]
Moist Heat or Steam Sterilization
[10381780428473]
Moist Heat or Steam Sterilization
[10381780428473]
Moist Heat or Steam Sterilization
[10381780428473]
Moist Heat or Steam Sterilization
[10381780428473]
Moist Heat or Steam Sterilization
[10381780428473]
Moist Heat or Steam Sterilization
[10381780428473]
Moist Heat or Steam Sterilization
[10381780428473]
Moist Heat or Steam Sterilization
[10381780428473]
Moist Heat or Steam Sterilization
[10381780428473]
Moist Heat or Steam Sterilization
[10381780428473]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-04-12 |
| Device Publish Date | 2019-04-04 |
On-Brand Devices [Integra®]
| 10381780429425 | Fenestrated jaws insert, double-action, 15x5mm jaws, for tube 5mm diam., 410mm length |
| 10381780429418 | Fenestrated insert, 45mm jaws, for tube 5mm diam., 410mm length |
| 10381780429401 | Needle holder insert tin corated diam. 5mm, 410mm length |
| 10381780429395 | SHEATH DIA5MM 410MM FOR TUBE CEV9649B5U (PK3) |
| 10381780429388 | Delaitre dissector insert, large curved 20mm jaws, for tube 5mm diam., 410mm length |
| 10381780429371 | Dissector insert, medium curved 20mm jaws, for tube 5mm diam., 410mm length |
| 10381780429364 | Fenestrated insert, double-action 20mm jaws, for tube 5mm diam., 410mm length |
| 10381780429357 | Bertrand fenestrated insert, curved 20mm jaws, for tube 5mm diam., 410mm length |
| 10381780429340 | Fenestrated insert jaws, 20mm tips, for tube 5mm diam., 410mm length |
| 10381780429333 | Serrated jaws insert for tube 5mm diam., 410mm length |
| 10381780429326 | Straight scissors insert for tube 5mm diam., 410mm length |
| 10381780429319 | Alligator insert, 20mm jaws, for tube 5mm diam., 410mm length |
| 10381780429302 | Dolphin insert, 20mm jaws, for tube 5mm diam., 410mm length |
| 10381780429296 | Alligator insert, 15mm jaws, for tube 5mm diam., 410mm length |
| 10381780429289 | Alligator insert, 10mm jaws, for tube 5mm diam., 410mm length |
| 10381780429272 | Cobra insert with double-action jaws for tube 5mm diam., 410mm length |
| 10381780429265 | Grasping insert for tube 5mm diam., 410mm length |
| 10381780429258 | Wire insert for jaws CEV607U CEV607CU CEV607DU, 410mm |
| 10381780429241 | Very curved insulated titanium scissors insert for tube diam. 5mm, 410mm length |
| 10381780429234 | Very curved insulated scissors insert for tube 5mm diam., 410mm length (3/pk) |
| 10381780429227 | Very curved scissors insert for tube 5mm diam., 410mm length |
| 10381780429210 | Curved scissors insert for tube 5mm diam., 410mm length |
| 10381780429203 | Cau needle holder insert, right curved jaws, for tube 5mm diam., 410mm length |
| 10381780429197 | Needle holder insert, carbide straight jaws, for tube 5mm diam., 410mm length |
| 10381780429180 | Knot guide scissors insert for tube 5mm diam., 410mm length |
| 10381780429173 | Demaizieres fenestrated insert, 20x3mm jaws, for tube 5mm diam., 410mm length |
| 10381780429166 | Oval curette insert for tube 5mm diam., 410mm length |
| 10381780429159 | Straight scissors insert with serrated blades for tube 5mm diam., 410mm length |
| 10381780429142 | Fenestrated jaws insert, double-action, 15x5mm jaws, for tube 5mm diam., 210mm length |
| 10381780429135 | Fenestrated insert, 45mm jaws, for tube 5mm diam., 210mm length |
| 10381780429128 | Needle holder insert tin corated diam. 5mm, 210 mm length |
| 10381780429111 | SHEATH DIA5MM 210MM FOR TUBE CEV649B5U (PK3) |
| 10381780429104 | Delaitre dissector insert, large curved 20mm jaws, for tube 5mm diam., 210mm length |
| 10381780429098 | Dissector insert, medium curved 20mm jaws for tube 5mm diam., 210mm length |
| 10381780429081 | Fenestrated insert, smooth 20mm jaws, for tube 5mm diam., 210mm length |
| 10381780429074 | Fenestrated insert, double-action 20mm jaws, for tube 5mm diam., 210mm length |
| 10381780429067 | Bertrand fenestrated insert, curved 20mm jaws, for tube 5mm diam., 210mm length |
| 10381780429050 | Fenestrated insert, 20mm jaws, for tube 5mm diam., 210mm length |
| 10381780429043 | Serrated jaws insert for tube 5mm diam., 210mm length |
| 10381780429036 | Straight scissors insert for tube 5mm diam., 210mm length |
| 10381780429029 | Babcock insert for tube 5mm diam., 210mm length |
| 10381780429012 | Fenestrated insert, 20mm jaws with teeth, for tube 5mm diam., 210mm length |
| 10381780429005 | Alligator insert, 15mm jaws, for tube 5mm diam., 210mm length |
| 10381780428992 | Tiger insert for tube 5mm diam., 210mm length |
| 10381780428985 | Cobra insert double-action jaws for tube 5mm diam., 210mm length |
| 10381780428978 | Grasping insert for tube 5mm diam., 210mm length |
| 10381780428961 | Wire insert for jaws CEV607U CEV607CU CEV607Du, 210mm length |
| 10381780428954 | Very curved insulated titanium scissors insert for tube diam. 5mm, 210mm length |
| 10381780428947 | Very curved insulated scissors insert for tube 5mm diam., 210mm length (3/pk) |
| 10381780428930 | Very curved scissors insert for tube 5mm diam., 210mm length |
Trademark Results [Integra]
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.