Integra®
Integra® Cranial access kit (without Prep solutions) Bit and Guard
2manufacturers in China registered for this device type
7catalogue numbers in this listing
14recalls on this code
Who Else Makes It
All of them in Shanghai. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Shanghai Wilpower Industrial Co., Ltd. | Shanghai | Shanghai | Exporter | 33 |
Record
| Listed by | Integra Pain Management, United States |
|---|---|
| FDA product code | HBG |
| Device type | Drills, Burrs, Trephines & Accessories (Manual) |
| Device class | Class 2 |
| Regulation | 21 CFR 882.4300 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| 510(k) | K961113 |
| Record published | 2024-11-19 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Do not use if package is damaged |
| Packaging | Box of 5 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| INS030 | In distribution | |
| INS5HND | In distribution | |
| HITHSP06 | In distribution | |
| HITHSP04 | In distribution | |
| SP0088 | 1/4″ (6.35 mm) | In distribution |
| SP0087 | 13/64″ (5.31 mm) | In distribution |
| SP0075 | 5/32″ (3.97 mm) | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Integra® Ruggles®-Redmond™ | Integra LifeSciences Production Corporation | 508 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 172 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 65 |
| Drills, Burrs, Trephines & Accessories (Manual) | Synthes Gmbh | 34 |
| Symmetry Surgical | Aspen Surgical Products, Inc. | 6 |
| Symmetry Hudson | Aspen Surgical Products, Inc. | 5 |
| Symmetry Cushing | Aspen Surgical Products, Inc. | 4 |
| V. Mueller | Steris Corporation | 3 |
| SmartTip | ClearPoint Neuro Inc. | 3 |
| Drill Bit | Neurovention, LLC | 2 |
| Codman® | Integra LifeSciences Production Corporation | 2 |
| Disposable Drill Kit | AD-Tech Medical Instrument Corp. | 2 |
Showing 12 of 41. All products under Drills, Burrs, Trephines & Accessories (Manual)
Recalls Naming This Product
37 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Integra Lifesciences Corporation | 510(k) number | 2024-04-17 | Class II | Process control | Potential holes and tears in the sterile packaging (header bag) of the Cranial Access Kit may compromise the sterility of the device. | 1,822 units | |
| Integra Lifesciences Corporation | 510(k) number | 2024-01-19 | Class II | Process control | A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised. | 4 units | |
| Integra Lifesciences Corporation | 510(k) number | 2024-01-19 | Class II | Process control | A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised. | 27 units | |
| Integra Lifesciences Corporation | 510(k) number | 2024-01-19 | Class II | Process control | A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised. | 23 units | |
| Integra Lifesciences Corporation | 510(k) number | 2024-01-19 | Class II | Process control | A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised. | 1324 units | |
| Integra Lifesciences Corporation | 510(k) number | 2024-01-19 | Class II | Process control | A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised. | 188 units | |
| Integra Lifesciences Corporation | 510(k) number | 2024-01-19 | Class II | Process control | A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised. | 161 units | |
| Integra Lifesciences Corporation | 510(k) number | 2024-01-19 | Class II | Process control | A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised. | 30 units | |
| Integra Lifesciences Corporation | 510(k) number | 2024-01-19 | Class II | Process control | A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised. | 82 units | |
| Integra Lifesciences Corporation | 510(k) number | 2024-01-19 | Class II | Process control | A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised. | 8906 units | |
| Integra Lifesciences Corporation | 510(k) number | 2024-01-19 | Class II | Process control | A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised. | 915 units | |
| Integra Lifesciences Corporation | 510(k) number | 2024-01-19 | Class II | Process control | A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised. | 6093 units | |
| Integra Lifesciences Corporation | 510(k) number | 2023-10-19 | Class II | Process control | Defect in the outer packaging of the Cranial Access Kits can cause the packaging to split without any additional forces outside compromising the sterility of the device | 1639 units | |
| Integra Lifesciences Corporation | 510(k) number | 2023-10-19 | Class II | Process control | Defect in the outer packaging of the Cranial Access Kits can cause the packaging to split without any additional forces outside compromising the sterility of the device | 173 units | |
| Integra Lifesciences Corporation | 510(k) number | 2023-10-19 | Class II | Process control | Defect in the outer packaging of the Cranial Access Kits. can cause the packaging to split without any additional forces outside compromising the sterility of the device | 59 units | |
| Integra Lifesciences Corporation | 510(k) number | 2023-10-19 | Class II | Process control | Defect in the outer packaging of the Cranial Access Kits. can cause the packaging to split without any additional forces outside compromising the sterility of the device | 180 units | |
| Integra Lifesciences Corporation | 510(k) number | 2023-10-19 | Class II | Process control | Defect in the outer packaging of the Cranial Access Kits. can cause the packaging to split without any additional forces outside compromising the sterility of the device | 510 units | |
| Integra Lifesciences Corporation | 510(k) number | 2023-10-19 | Class II | Process control | Defect in the outer packaging of the Cranial Access Kits. can cause the packaging to split without any additional forces outside compromising the sterility of the device | 485 units | |
| Integra Lifesciences Corporation | 510(k) number | 2023-10-19 | Class II | Process control | Defect in the outer packaging of the Cranial Access Kits. can cause the packaging to split without any additional forces outside compromising the sterility of the device | 160 units | |
| Integra Lifesciences Corporation | 510(k) number | 2023-10-19 | Class II | Process control | Defect in the outer packaging of the Cranial Access Kits. can cause the packaging to split without any additional forces outside compromising the sterility of the device | 173 units | |
| Integra Lifesciences Corporation | 510(k) number | 2023-10-19 | Class II | Process control | Defect in the outer packaging of the Cranial Access Kits. can cause the packaging to split without any additional forces outside compromising the sterility of the device | 1 unit | |
| Integra Pain Management | 510(k) number | 2016-08-24 | Class II | Packaging | Integra LifeSciences has been notified of a medical device recall by Adaptive Surgical, LLC involving their Riverlon” Nylon 3-0 Sutures that are packaged in Integras Cranial Access Kits. It was found that product seals may become open durin | 710 | 2017-03-30 |
| Integra Pain Management | 510(k) number | 2011-12-21 | Not classified | Labeling False and Misleading | Current package insert was revised to include additional warning information related to the potential hazards of an unapproved off-label use of Xylocaine. | 117 kits | 2012-05-10 |
| Integra Pain Management | 510(k) number | 2011-12-21 | Not classified | Labeling False and Misleading | Current package insert was revised to include additional warning information related to the potential hazards of an unapproved off-label use of Xylocaine. | 24690 units | 2012-05-10 |
| Integra Pain Management | 510(k) number | 2011-12-21 | Not classified | Labeling False and Misleading | Current package insert was revised to include additional warning information related to the potential hazards of an unapproved off-label use of Xylocaine. | 1,160 units. | 2012-05-10 |
| Integra Pain Management | 510(k) number | 2011-12-21 | Not classified | Labeling False and Misleading | Current package insert was revised to include additional warning information related to the potential hazards of an unapproved off-label use of Xylocaine. | 210 units. | 2012-05-10 |
| Integra Pain Management | 510(k) number | 2011-12-21 | Not classified | Labeling False and Misleading | Current package insert was revised to include additional warning information related to the potential hazards of an unapproved off-label use of Xylocaine. | 373 units. | 2012-05-10 |
| Integra Pain Management | 510(k) number | 2011-12-21 | Not classified | Labeling False and Misleading | Current package insert was revised to include additional warning information related to the potential hazards of an unapproved off-label use of Xylocaine. | 112 units. | 2012-05-10 |
| Integra Pain Management | 510(k) number | 2011-12-21 | Not classified | Labeling False and Misleading | Current package insert was revised to include additional warning information related to the potential hazards of an unapproved off-label use of Xylocaine. | 11 units | 2012-05-10 |
| Integra Pain Management | 510(k) number | 2011-12-21 | Not classified | Labeling False and Misleading | Current package insert was revised to include additional warning information related to the potential hazards of an unapproved off-label use of Xylocaine. | 12 units | 2012-05-10 |
| Integra Pain Management | 510(k) number | 2011-12-21 | Not classified | Labeling False and Misleading | Current package insert was revised to include additional warning information related to the potential hazards of an unapproved off-label use of Xylocaine. | 62 units. | 2012-05-10 |
| Integra Pain Management | 510(k) number | 2011-12-21 | Not classified | Labeling False and Misleading | Current package insert was revised to include additional warning information related to the potential hazards of an unapproved off-label use of Xylocaine. | 1,159 units. | 2012-05-10 |
| Integra Pain Management | 510(k) number | 2011-12-21 | Not classified | Labeling False and Misleading | Current package insert was revised to include additional warning information related to the potential hazards of an unapproved off-label use of Xylocaine. | 2,305 units | 2012-05-10 |
| Integra Pain Management | 510(k) number | 2011-12-21 | Not classified | Labeling False and Misleading | Current package insert was revised to include additional warning information related to the potential hazards of an unapproved off-label use of Xylocaine. | 180 units. | 2012-05-10 |
| Integra Lifesciences Corporation | 510(k) number | 2011-02-22 | Not classified | Error in labeling | Outer box of Monitoring Kit was mislabeled with the incorrect part number. | 45 kits | 2011-05-10 |
| Integra Lifesciences Corporation | 510(k) number | 2011-02-22 | Not classified | Labeling mix-ups | Outer packaging of Combo Kit was mislabeled with an incorrect lot number. | 7 Kits | 2011-05-13 |
| Integra Pain Management | 510(k) number | 2009-07-13 | Not classified | Packaging process control | Lack of packaging seal integrity on various pain management kits may compromise sterility of contents. | 44 units | 2009-10-23 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.