Millennium
- Primary DI
- 00190776352721
- Brand
- Millennium
- Company
- Avalign Technologies, Inc.
- Model
- 10-430108
- Device description
- Laforce Adenotome Blade
- Published
- 2023-11-17
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- false
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| KBH | Adenotome | Ear, Nose, Throat | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00190776352721 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00190776352721 | 00190776352721 | 190776352721 | 0190776352721 |
GMDN Terms
| Term | Definition |
|---|
| Hand-held surgical retractor, reusable | A hand-held, non-self-retaining 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 dedicated to ophthalmic surgery or small nerve/vessel retraction, but may otherwise be clinically dedicated. It includes a shaped/hooked blade with a handle/holding portion and is available in a wide variety of designs, such as a double- or single-ended blade that may be fenestrated (pronged); deep wound retractors are typically designed with a long, curved blade that may also be intended to retract organs; it may include a light. This is a reusable device. |
Sterilization Methods
| Method |
|---|
| Moist Heat or Steam Sterilization |
Regulatory Flags
- DUNS number
- 792528510
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- 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
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|
| 00757770420322 | Bausch + Lomb | Bausch & Lomb Incorporated | KBH | 2025-07-29 |
| 00757770424443 | Bausch + Lomb | Bausch & Lomb Incorporated | KBH | 2025-07-29 |
| 00757770429974 | Bausch + Lomb | Bausch & Lomb Incorporated | KBH | 2025-07-29 |
| 00757770430055 | Bausch + Lomb | Bausch & Lomb Incorporated | KBH | 2025-07-29 |
| 00190776381943 | Millennium | Avalign Technologies, Inc. | KBH | 2024-04-30 |
| G586E8221210 | Novo Surgical | NOVO SURGICAL, INC. | KBH | 2023-12-18 |
| G586E8221220 | Novo Surgical | NOVO SURGICAL, INC. | KBH | 2023-12-18 |
| G586E8221230 | Novo Surgical | NOVO SURGICAL, INC. | KBH | 2023-12-18 |
| G586E8221240 | Novo Surgical | NOVO SURGICAL, INC. | KBH | 2023-12-18 |
| G586E8221720 | Novo Surgical | NOVO SURGICAL, INC. | KBH | 2023-12-18 |
| G586E8221730 | Novo Surgical | NOVO SURGICAL, INC. | KBH | 2023-12-18 |
| G586E8221740 | Novo Surgical | NOVO SURGICAL, INC. | KBH | 2023-12-18 |
| 00190776049430 | Avalign | Avalign Technologies, Inc. | KBH | 2023-09-28 |
| 00190776227999 | Avalign | Avalign Technologies, Inc. | KBH | 2023-09-28 |
| 00190776228002 | Avalign | Avalign Technologies, Inc. | KBH | 2023-09-28 |
| 00190776228019 | Avalign | Avalign Technologies, Inc. | KBH | 2023-09-28 |
| 00190776327194 | Millennium | AVALIGN TECHNOLOGIES, INC. | KBH | 2023-06-23 |
| G22313594910 | Medetz Surgical Instruments | Medetz Surgical Instruments LLC | KBH | 2023-06-08 |
| 00887482192825 | Symmetry Surgical | SYMMETRY SURGICAL INC. | KBH | 2022-12-08 |
| 00887482192832 | Symmetry Surgical | SYMMETRY SURGICAL INC. | KBH | 2022-12-08 |
| 00842331170294 | Novo Surgical Inc. | NOVO SURGICAL, INC. | KBH | 2022-11-13 |
| 00190660000103 | Ambler Surgical | AMBLER SURGICAL CORP. | KBH | 2021-01-04 |
| 00190660000110 | Ambler Surgical | AMBLER SURGICAL CORP. | KBH | 2021-01-04 |
| 00190660000127 | Ambler Surgical | AMBLER SURGICAL CORP. | KBH | 2021-01-04 |
| 00190660000134 | Ambler Surgical | AMBLER SURGICAL CORP. | KBH | 2021-01-04 |
| 00190660000141 | Ambler Surgical | AMBLER SURGICAL CORP. | KBH | 2021-01-04 |
| 00190660000158 | Ambler Surgical | AMBLER SURGICAL CORP. | KBH | 2021-01-04 |
| 00190660000165 | Ambler Surgical | AMBLER SURGICAL CORP. | KBH | 2021-01-04 |
| 00190660000172 | Ambler Surgical | AMBLER SURGICAL CORP. | KBH | 2021-01-04 |
| 00190660000189 | Ambler Surgical | AMBLER SURGICAL CORP. | KBH | 2021-01-04 |
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