MILLENNIUM
- Primary DI
- 00190776378264
- Brand
- MILLENNIUM
- Company
- Avalign Technologies, Inc.
- Model
- 85-90011950
- Device description
- Paparella Needle, #6, heavy,
- Published
- 2023-09-28
- 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 Codes
| Code | Name |
|---|
| KBR | NEEDLE, TONSIL SUTURING |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| KBR | Needle, Tonsil Suturing | Ear, Nose, Throat | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00190776378264 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00190776378264 | 00190776378264 | 190776378264 | 0190776378264 |
GMDN Terms
| Term | Definition |
|---|
| Eye spud/needle | A hand-held manual ophthalmic surgical instrument intended to be used to remove a foreign body/object embedded in or adhering to the surface of the eye globe. It is typically made of high-grade stainless steel, and designed with a fine handle in the centre of the instrument. At one end is a thin concave blade with a rounded nose (spud), and at the other end is a spearhead-shaped needle. The ophthalmologist uses these tips to remove the foreign body/object. 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
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| 00194613046040 | MSI Precision Specialty Instruments | Med Saver, Inc. | KBR | 2025-08-01 |
| 00194613112448 | MSI Precision Specialty Instruments | Med Saver, Inc. | KBR | 2025-08-01 |
| 00194613115449 | MSI Precision Specialty Instruments | Med Saver, Inc. | KBR | 2025-08-01 |
| 00194613109752 | MSI Precision Specialty Instruments | Med Saver, Inc. | KBR | 2025-03-21 |
| 00190776388744 | Millennium | Avalign Technologies, Inc. | KBR | 2024-11-14 |
| 00887482173800 | Symmetry Surgical® | SYMMETRY SURGICAL INC. | KBR | 2024-08-15 |
| 00887482046562 | Symmetry Surgical® | SYMMETRY SURGICAL INC. | KBR | 2024-08-01 |
| 00887482119167 | Symmetry Surgical® | SYMMETRY SURGICAL INC. | KBR | 2024-08-01 |
| 00887482119174 | Symmetry Surgical® | SYMMETRY SURGICAL INC. | KBR | 2024-08-01 |
| 00887482123966 | Symmetry Surgical® | SYMMETRY SURGICAL INC. | KBR | 2024-08-01 |
| 00887482123973 | Symmetry Surgical® | SYMMETRY SURGICAL INC. | KBR | 2024-08-01 |
| 00840343722203 | GEN2 | SURGIX MEDICAL LLC | KBR | 2024-04-23 |
| G586E8306200 | Novo Surgical | NOVO SURGICAL, INC. | KBR | 2023-12-18 |
| 00840343720414 | GEN2 | SURGIX MEDICAL LLC | KBR | 2023-12-08 |
| 00190776303990 | Millennium | Avalign Technologies, Inc. | KBR | 2023-11-16 |
| 00190776304904 | Millennium | Avalign Technologies, Inc. | KBR | 2023-11-16 |
| 00190776044077 | Avalign | Avalign Technologies, Inc. | KBR | 2023-09-28 |
| 00190776290733 | MILLENNIUM | Avalign Technologies, Inc. | KBR | 2023-09-28 |
| 00190776319625 | MILLENNIUM | Avalign Technologies, Inc. | KBR | 2023-09-28 |
| 00190776319700 | MILLENNIUM | Avalign Technologies, Inc. | KBR | 2023-09-28 |
| 00190776319885 | MILLENNIUM | Avalign Technologies, Inc. | KBR | 2023-09-28 |
| 00190776322281 | MILLENNIUM | Avalign Technologies, Inc. | KBR | 2023-09-28 |
| 00190776322298 | MILLENNIUM | Avalign Technologies, Inc. | KBR | 2023-09-28 |
| 00190776373801 | MILLENNIUM | Avalign Technologies, Inc. | KBR | 2023-09-28 |
| 00840343716240 | GEN2 | SURGIX MEDICAL LLC | KBR | 2023-03-22 |
| 54026704805025 | PILLING | TELEFLEX INCORPORATED | KBR | 2022-12-08 |
| 54026704805032 | PILLING | TELEFLEX INCORPORATED | KBR | 2022-12-08 |
| 54026704805346 | PILLING | TELEFLEX INCORPORATED | KBR | 2022-12-08 |
| 54026704805513 | PILLING | TELEFLEX INCORPORATED | KBR | 2022-12-08 |
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