NA
- Primary DI
- 00845384011194
- Brand
- NA
- Company
- Anspach Effort, The
- Model
- IMRI-S-8NS-M
- Catalog number
- IMRI-S-8NS-M
- Device description
- 3 mm Fluted Matchstick, Extends 8.9 mm, Less Aggressive. Use with IMRI-SHORT Attachment.
- Published
- 2016-09-09
- Public version status
- Update
- Distribution status
- Not in Commercial Distribution
- MRI safety
- MR Conditional
- Rx
- true
- Sterile
- true
- Single use
- true
Contact Domains#
its.jnj.comProduct Codes#
Product Code Classifications#
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K040186 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00845384011194 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00845384011194 | 00845384011194 | 845384011194 | 0845384011194 |
GMDN Terms#
| Term | Definition |
|---|---|
| Cranial bur, single-use | A rotary cutting device consisting of a shaft of high-grade steel and a cutting head of hard metal and/or diamond material with fluting or cutting planes of various shapes at the working end and which is designed to fit into an appropriate powered handpiece that provides the rotation allowing the user to excavate soft or hard skull tissue. This is a single-use device. |
Sterilization Methods#
| Method |
|---|
Contacts#
| Phone | |
|---|---|
| +1(800)255-2500 | RA-DPYNA-anspachpowe@its.jnj.com |
Regulatory Flags#
- DUNS number
- 079116867
- Device count
- 1
- Lot or batch
- true
- Expiration date on label
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 00845384018759 | EG1™ | WIRELESS-HC | WIRELESS-HC | 2022-07-08 |
| 00845384018766 | EG1™ | RECEIVER-HC | RECEIVER-HC | 2022-07-08 |
| 00845384014249 | NA | L-5B-A-G1 | L-5B-A-G1 | 2016-09-09 |
| 00845384012269 | NA | HK-2100-02-FP | HK-2100-02-FP | 2016-10-17 |
| 00845384012290 | NA | AL-9152-00-FP | AL-9152-00-FP | 2016-10-17 |
| 00845384002536 | NA | HOSE-20-DISS | HOSE-20-DISS | 2016-10-17 |
| 00845384005599 | NA | MUFFLER-ASSY | MUFFLER-ASSY | 2016-10-17 |
| 00845384010784 | NA | XM-CASE | XM-CASE | 2018-02-05 |
| 00845384010791 | NA | XMAX | XMAX | 2018-02-05 |
| 00845384012276 | NA | 16-3100-FP | 16-3100-FP | 2016-09-09 |
| 00845384012313 | NA | HE-4005-10-FP | HE-4005-10-FP | 2016-09-09 |
| 00845384012320 | NA | 45-0432-FP | 45-0432-FP | 2016-09-09 |
| 00845384016595 | NA | E-HC | E-HC | 2018-02-05 |
| 00845384006343 | NA | QD11-8ND | QD11-8ND | 2016-09-09 |
| 00845384016588 | NA | MIA16-5DRM | MIA16-5DRM | 2016-09-09 |
| 00845384000396 | NA | AUTOLUBE-III | AUTOLUBE-III | 2016-10-17 |
| 00845384000402 | NA | AUTOLUBE-III-20 | AUTOLUBE-III-20 | 2016-10-17 |
| 00845384000457 | NA | AUTOLUBE-III-IRR | AUTOLUBE-III-IRR | 2016-10-17 |
| 00845384000464 | NA | AUTOLUBE-III-MA7 | AUTOLUBE-III-MA7 | 2016-10-17 |
| 00845384001676 | NA | CDA | CDA | 2018-02-05 |
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| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 00816589021615 | Brasseler Twist Drillbit | MONTERIS MEDICAL INC | HBE | 2026-07-03 |
| 00816589021622 | Brasseler Twist Drillbit | MONTERIS MEDICAL INC | HBE | 2026-07-03 |
| 04589551366217 | P300-2A100 | NAKANISHI INC. | HBE | 2026-06-26 |
| 04589551366262 | P300-2A120 | NAKANISHI INC. | HBE | 2026-06-26 |
| 04589551366316 | P300-2S100 | NAKANISHI INC. | HBE | 2026-06-26 |
| 04589551366361 | P300-2S120 | NAKANISHI INC. | HBE | 2026-06-26 |
| 07630055505675 | PM2-A70 | Bien-Air Surgery SA | HBE | 2023-02-09 |
| 07630055505682 | PM2-A150 | Bien-Air Surgery SA | HBE | 2023-02-09 |
| 07630055505699 | PM2-S70 | Bien-Air Surgery SA | HBE | 2023-02-09 |
| 07613327504019 | NA | STRYKER CORPORATION | HBE | 2021-07-08 |
| 07613327504057 | NA | STRYKER CORPORATION | HBE | 2021-07-08 |
| 04546540246332 | NA | Stryker Leibinger GmbH & Co. KG | HBE | 2016-08-24 |
| 04546540246356 | NA | Stryker Leibinger GmbH & Co. KG | HBE | 2016-08-24 |
| 04546540246387 | NA | Stryker Leibinger GmbH & Co. KG | HBE | 2016-08-24 |
| 04546540246974 | NA | Stryker Leibinger GmbH & Co. KG | HBE | 2016-08-24 |
| 04546540246981 | NA | Stryker Leibinger GmbH & Co. KG | HBE | 2016-08-24 |
| 04546540251862 | NA | Stryker Leibinger GmbH & Co. KG | HBE | 2016-08-24 |
| 04546540356499 | NA | Stryker Leibinger GmbH & Co. KG | HBE | 2016-08-24 |
| 04546540356505 | NA | Stryker Leibinger GmbH & Co. KG | HBE | 2016-08-24 |
| 04546540356512 | NA | Stryker Leibinger GmbH & Co. KG | HBE | 2016-08-24 |
| 04546540356529 | NA | Stryker Leibinger GmbH & Co. KG | HBE | 2016-08-24 |
| 04546540356536 | NA | Stryker Leibinger GmbH & Co. KG | HBE | 2016-08-24 |
| 04546540356543 | NA | Stryker Leibinger GmbH & Co. KG | HBE | 2016-08-24 |
| 04546540356567 | NA | Stryker Leibinger GmbH & Co. KG | HBE | 2016-08-24 |
| 04546540366467 | NA | Stryker Leibinger GmbH & Co. KG | HBE | 2016-08-24 |
| 04546540366481 | NA | Stryker Leibinger GmbH & Co. KG | HBE | 2016-08-24 |
| 04546540366498 | NA | Stryker Leibinger GmbH & Co. KG | HBE | 2016-08-24 |
| 04546540366504 | NA | Stryker Leibinger GmbH & Co. KG | HBE | 2016-08-24 |
| 04546540366511 | NA | Stryker Leibinger GmbH & Co. KG | HBE | 2016-08-24 |
| 04546540366528 | NA | Stryker Leibinger GmbH & Co. KG | HBE | 2016-08-24 |