INKA
- Primary DI
- 09348811114075
- Brand
- INKA
- Company
- The Trustee for KAISER FAMILY TRUST
- Model
- 30728.17
- Device description
- FISCH Stapedectomy Retractor self-arresting arms solid blade right side 17cm
- Published
- 2026-05-29
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- false
Product Codes#
| Code | Name |
|---|---|
| FFO | Retractor, Self-Retaining |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| FFO | Retractor, Self-Retaining | Gastroenterology, Urology | 1 |
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 09348811114075 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 09348811114075 | 09348811114075 | 9348811114075 |
GMDN Terms#
| Term | Definition |
|---|---|
| Self-retaining surgical retractor, reusable | A hand-operated, self-retaining, one-piece surgical instrument intended to be used to separate/draw aside the margins of a wound/incision to allow access to tissues/organs during open surgery; it is not intended to retract the ribs and is not dedicated to ophthalmic surgery, but may otherwise be clinically dedicated. It is designed as a one-piece device (i.e., not a mounting ring, or table-fixed assembly) having two legs with distal hooked blades and a self-retaining mechanism to maintain the legs in an open position for retraction. This is a reusable device. |
Sterilization Methods#
| Method |
|---|
| Moist Heat or Steam Sterilization |
Regulatory Flags#
- DUNS number
- 742109993
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- true
- Manufacturing date on label
- true
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 09348811022066 | INKA | 31654.08 | 2026-06-02 | |
| 09348811105868 | INKA | 31740.08 | 2026-06-02 | |
| 09348811111944 | INKA | 31252.10 | 2026-06-02 | |
| 09348811115461 | INKA | 36187.13 | 2026-06-02 | |
| 09348811148858 | INKA | 30149.05 | 2026-06-02 | |
| 09348811148889 | INKA | 30149.08 | 2026-06-02 | |
| 09348811148957 | INKA | 30124.50 | 2026-06-02 | |
| 09348811100603 | INKA | 30260.00 | 2026-05-29 | |
| 09348811100825 | INKA | 31210.01 | 2026-05-29 | |
| 09348811100832 | INKA | 31210.02 | 2026-05-29 | |
| 09348811105417 | INKA | 30445.25 | 2026-05-29 | |
| 09348811109439 | INKA | 31405.50 | 2026-05-29 | |
| 09348811114068 | INKA | 30727.17 | 2026-05-29 | |
| 09348811148919 | INKA | 30124.30 | 2026-05-29 | |
| 09348811148933 | INKA | 30124.40 | 2026-05-29 | |
| 09348811150301 | INKA | 31243.16 RD | 2026-05-29 | |
| 09348811150318 | INKA | 31252.04 RD | 2026-05-29 | |
| 09348811150325 | INKA | 31252.06 RD | 2026-05-29 | |
| 09348811150349 | INKA | 31252.10 RD | 2026-05-29 | |
| 09348811150363 | INKA | 31252.15 RD | 2026-05-29 |
Other Devices Sharing Product Codes#
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 09348811114068 | INKA | The Trustee for KAISER FAMILY TRUST | FFO | 2026-05-29 |
| 09348811023612 | INKA | The Trustee for KAISER FAMILY TRUST | FFO | 2025-11-19 |
| 07898506813698 | Quinelato | Schobell Industrial Ltda | FFO | 2022-12-16 |
| 10381780268437 | Omni-Tract® | INTEGRA LIFESCIENCES CORPORATION | FFO | 2018-10-23 |
| 10381780268420 | Omni-Tract® | INTEGRA LIFESCIENCES CORPORATION | FFO | 2018-05-03 |
| 10381780268499 | Omni-Tract® | INTEGRA LIFESCIENCES CORPORATION | FFO | 2018-05-03 |
| 10381780269397 | Omni-Tract® | INTEGRA LIFESCIENCES CORPORATION | FFO | 2018-05-03 |
| 10381780269427 | Omni-Tract® | INTEGRA LIFESCIENCES CORPORATION | FFO | 2018-05-03 |
| 10381780269489 | Omni-Tract® | INTEGRA LIFESCIENCES CORPORATION | FFO | 2018-05-03 |
| 10381780269564 | Omni-Tract® | INTEGRA LIFESCIENCES CORPORATION | FFO | 2018-05-03 |
| 10381780269663 | Omni-Tract® | INTEGRA LIFESCIENCES CORPORATION | FFO | 2018-05-03 |
| 10381780269670 | Omni-Tract® | INTEGRA LIFESCIENCES CORPORATION | FFO | 2018-05-03 |
| 10381780269694 | Omni-Tract® | INTEGRA LIFESCIENCES CORPORATION | FFO | 2018-05-03 |
| 10381780269724 | Omni-Tract® | INTEGRA LIFESCIENCES CORPORATION | FFO | 2018-05-03 |
| 10381780269748 | Omni-Tract® | INTEGRA LIFESCIENCES CORPORATION | FFO | 2018-05-03 |
| 10381780269762 | Omni-Tract® | INTEGRA LIFESCIENCES CORPORATION | FFO | 2018-05-03 |
| 10381780269779 | Omni-Tract® | INTEGRA LIFESCIENCES CORPORATION | FFO | 2018-05-03 |
| 10381780269816 | Omni-Tract® | INTEGRA LIFESCIENCES CORPORATION | FFO | 2018-05-03 |
| 10381780268413 | Omni-Tract® | INTEGRA LIFESCIENCES CORPORATION | FFO | 2018-02-23 |
| 10381780268444 | Omni-Tract® | INTEGRA LIFESCIENCES CORPORATION | FFO | 2018-02-23 |
| 10381780268451 | Omni-Tract® | INTEGRA LIFESCIENCES CORPORATION | FFO | 2018-02-23 |
| 10381780268468 | Omni-Tract® | INTEGRA LIFESCIENCES CORPORATION | FFO | 2018-02-23 |
| 10381780268475 | Omni-Tract® | INTEGRA LIFESCIENCES CORPORATION | FFO | 2018-02-23 |
| 10381780268482 | Omni-Tract® | INTEGRA LIFESCIENCES CORPORATION | FFO | 2018-02-23 |
| 10381780268505 | Omni-Tract® | INTEGRA LIFESCIENCES CORPORATION | FFO | 2018-02-23 |
| 10381780268512 | Omni-Tract® | INTEGRA LIFESCIENCES CORPORATION | FFO | 2018-02-23 |
| 10381780268529 | Omni-Tract® | INTEGRA LIFESCIENCES CORPORATION | FFO | 2018-02-23 |
| 10381780268543 | Omni-Tract® | INTEGRA LIFESCIENCES CORPORATION | FFO | 2018-02-23 |
| 10381780268550 | Omni-Tract® | INTEGRA LIFESCIENCES CORPORATION | FFO | 2018-02-23 |
| 10381780268567 | Omni-Tract® | INTEGRA LIFESCIENCES CORPORATION | FFO | 2018-02-23 |