Aztec
- Primary DI
- B87110157080
- Brand
- Aztec
- Company
- Aztecmed/Ent LLC
- Model
- 10-15708
- Catalog number
- 10-15708
- Device description
- Miniature Ear Cup Forceps, 0.7mm x 1mm fenestrated cups
- Published
- 2020-10-06
- 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
Related Records
Product Codes
| Code | Name |
|---|---|
| KAE | Forceps, Ent |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| KAE | Forceps, Ent | Ear, Nose, Throat | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| B87110157080 | Primary | HIBCC | 0 |
GMDN Terms
| Term | Definition |
|---|---|
| Surgical soft-tissue manipulation forceps, tweezers-like, reusable | A hand-held, manual, open-surgery instrument designed to facilitate grasping and manipulation of soft-tissues. It has a tweezers-like design (may be a micro/fine instrument) with variously designed tips at the working end, whereby the blades are designed to be opened/closed by squeezing between the fingers (i.e., without ring handles). It is made of high-grade stainless steel, available in various sizes, and may have carbide inserts at the working end. It is not an electrosurgical device and not dedicated to ophthalmic surgery. This is a reusable device intended to be sterilized prior to use. |
Sterilization Methods
| Method |
|---|
| Moist Heat or Steam Sterilization |
Regulatory Flags
- DUNS number
- 117559084
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- false
- Serial number
- false
- Manufacturing date on label
- false
- 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 |
|---|---|---|---|---|
| B87110204300 | Aztec | 10-20430 | 10-20430 | 2022-05-09 |
| B8711055400 | Aztec | 10-5540 | 2022-05-09 | |
| B8711055410 | Aztec | 10-5541 | 2022-05-09 | |
| B87110221100 | Aztec | 10-22110 | 10-22110 | 2022-02-15 |
| B87111151000 | Aztec | 11-15100 | 11-15100 | 2020-10-09 |
| B87111151100 | Aztec | 11-15110 | 11-15110 | 2020-10-09 |
| B87111151200 | Aztec | 11-15120 | 11-15120 | 2020-10-09 |
| B87111151300 | Aztec | 11-15130 | 11-15130 | 2020-10-09 |
| B87111151500 | Aztec | 11-15150 | 11-15150 | 2020-10-09 |
| B87111152000 | Aztec | 11-15200 | 11-15200 | 2020-10-09 |
| B87111153000 | Aztec | 11-15300 | 11-15300 | 2020-10-09 |
| B87111153050 | Aztec | 11-15305 | 11-15305 | 2020-10-09 |
| B87111153090 | Aztec | 11-15309 | 11-15309 | 2020-10-09 |
| B87111153200 | Aztec | 11-15320 | 11-15320 | 2020-10-09 |
| B87111154000 | Aztec | 11-15400 | 11-15400 | 2020-10-09 |
| B87111155000 | Aztec | 11-15500 | 11-15500 | 2020-10-09 |
| B87111155100 | Aztec | 11-15510 | 11-15510 | 2020-10-09 |
| B87111155110 | Aztec | 11-15511 | 11-15511 | 2020-10-09 |
| B87111155130 | Aztec | 11-15513 | 11-15513 | 2020-10-09 |
| B87111155150 | Aztec | 11-15515 | 11-15515 | 2020-10-09 |
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| 24026704934625 | PILLING | TELEFLEX INCORPORATED | KAE | 2026-03-06 |
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| 00190776417413 | Millennium | Avalign Technologies, Inc. | KAE | 2026-02-27 |
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| 00848657078214 | AED | NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. | KAE | 2026-02-18 |
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| 09008737448905 | SoftGrip Forceps 2 | Med-El Elektromedizinische Geräte Gesellschaft m.b.H. | KAE | 2026-02-04 |
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| G04362076B0 | BEAR | Bear-Ent, LLC | KAE | 2026-02-03 |
| 09348811103659 | INKA | The Trustee for KAISER FAMILY TRUST | KAE | 2026-01-28 |
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| 09348811104229 | INKA | The Trustee for KAISER FAMILY TRUST | KAE | 2025-12-01 |
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