Illy
- Primary DI
- 08052440100972
- Brand
- Illy
- Company
- MDL SRL
- Model
- PIL1635/100
- Catalog number
- PIL1635/100
- Device description
- 10 CS-DISPOSABLE BONE BIOPSY NEEDLE FOR ILIAC CREST MARROW ASPIRATION, "T" HANDLE 16G x 35/100 mm
- Published
- 2017-01-05
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Related Records
Product Codes
| Code | Name |
|---|---|
| DWO | Needle, Biopsy, Cardiovascular |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| DWO | Needle, Biopsy, Cardiovascular | General, Plastic Surgery | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 08052440100972 | Package | GS1 | 10 | In Commercial Distribution |
| 08032986359003 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 08052440100972 | 08052440100972 | 8052440100972 |
| 08032986359003 | 08032986359003 | 8032986359003 |
GMDN Terms
| Term | Definition |
|---|---|
| Bone marrow biopsy needle, single-use | A sterile, sharp bevel-edged, hollow tubular metal instrument designed to obtain a specimen of bone marrow percutaneously. The device is typically available in a variety of large bores, and is sufficiently robust to penetrate bone (usually the hip bone or posterior iliac crest) with the force of pressure and twisting manually applied to its proximal handgrip. The resultant specimen is typically used for the pathological analysis of the source of blood cellular elements. This is a single-use device. |
Device Sizes
| Type | Value | Unit |
|---|---|---|
| Needle Gauge | 16 | Gauge |
Sterilization Methods
| Method |
|---|
Regulatory Flags
- DUNS number
- 447228586
- 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
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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| 18056138586250 | AutoMark | PNA2005 | PNA2005 | 2021-05-17 |
| 18056138586267 | AutoMark | PNA2010 | PNA2010 | 2021-05-17 |
| 18056138586274 | AutoMark | PNA2015 | PNA2015 | 2021-05-17 |
| 18056138586304 | MarkSlim | PNS2010 | PNS2010 | 2021-05-17 |
| 18056138586311 | Markslim | PNS2015 | PNS2015 | 2021-05-17 |
| 08056138586352 | RepoMark | PR2005 | PR2005 | 2021-05-17 |
| 18056138586366 | RepoMark | PR2007 | PR2007 | 2021-05-17 |
| 18056138586373 | RepoMark | PR2010 | PR2010 | 2021-05-17 |
| 18056138586380 | RepoMark | PR2015 | PR2015 | 2021-05-17 |
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| 18056138586427 | PressTo | PS1306 | PS1306 | 2021-05-17 |
| 18056138586434 | PressTo | PS1310 | PS1310 | 2021-05-17 |
| 28056138586615 | Themy | TY1206 | TY1206 | 2021-05-17 |
| 28056138586622 | Themy | TY1209 | TY1209 | 2021-05-17 |
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| 28056138586646 | Themy | TY1410 | TY1410 | 2021-05-17 |
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