MammoStar™ STAR1033
GUDID 10858015005384
Biopsy Site Identifier - Revolve
Carbon Medical Technologies, Inc.
Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable| Primary Device ID | 10858015005384 |
| NIH Device Record Key | fa80952a-0dcc-416f-916f-da53e57f0d6a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MammoStar™ |
| Version Model Number | STAR1033 |
| Catalog Number | STAR1033 |
| Company DUNS | 883094039 |
| Company Name | Carbon Medical Technologies, Inc. |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | MR Safe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 8882070262 |
| info@carbonmed.com | |
| Phone | 8882070262 |
| info@carbonmed.com | |
| Phone | 8882070262 |
| info@carbonmed.com | |
| Phone | 8882070262 |
| info@carbonmed.com | |
| Phone | 8882070262 |
| info@carbonmed.com | |
| Phone | 8882070262 |
| info@carbonmed.com | |
| Phone | 8882070262 |
| info@carbonmed.com | |
| Phone | 8882070262 |
| info@carbonmed.com | |
| Phone | 8882070262 |
| info@carbonmed.com | |
| Phone | 8882070262 |
| info@carbonmed.com | |
| Phone | 8882070262 |
| info@carbonmed.com | |
| Phone | 8882070262 |
| info@carbonmed.com | |
| Phone | 8882070262 |
| info@carbonmed.com | |
| Phone | 8882070262 |
| info@carbonmed.com | |
| Phone | 8882070262 |
| info@carbonmed.com | |
| Phone | 8882070262 |
| info@carbonmed.com | |
| Phone | 8882070262 |
| info@carbonmed.com | |
| Phone | 8882070262 |
| info@carbonmed.com | |
| Phone | 8882070262 |
| info@carbonmed.com | |
| Phone | 8882070262 |
| info@carbonmed.com | |
| Phone | 8882070262 |
| info@carbonmed.com |
Device Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Outer Diameter | 2 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Outer Diameter | 2 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Outer Diameter | 2 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Outer Diameter | 2 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Outer Diameter | 2 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Outer Diameter | 2 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Outer Diameter | 2 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Outer Diameter | 2 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Outer Diameter | 2 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Outer Diameter | 2 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Outer Diameter | 2 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Outer Diameter | 2 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Outer Diameter | 2 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Outer Diameter | 2 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Outer Diameter | 2 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Outer Diameter | 2 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Outer Diameter | 2 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Outer Diameter | 2 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 9 Millimeter |
| Outer Diameter | 2 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
Operating and Storage Conditions
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00858015005387 [Primary] |
| GS1 | 10858015005384 [Package] Contains: 00858015005387 Package: Carton [10 Units] In Commercial Distribution |
FDA Product Code
| NEU | Marker, Radiographic, Implantable |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2015-09-24 |
On-Brand Devices [MammoStar™]
| 10858015005445 | Biopsy Site Identifier |
| 10858015005438 | Biopsy Site Identifier |
| 10858015005421 | Biopsy Site Identifier |
| 10858015005414 | Biopsy Site Identifier |
| 10858015005407 | Biopsy Site Identifier |
| 10858015005391 | Biopsy Site Identifier |
| 10858015005384 | Biopsy Site Identifier - Revolve |
| 10858015005377 | Biopsy Site Identifier - Revolve |
| 10858015005360 | Biopsy Site Identifier - Revolve |
| 10858015005353 | Biopsy Site Identifier |
| 10858015005346 | Biopsy Site Identifier - Revolve |
| 10858015005339 | Biopsy Site Identifier - Revolve |
| 10858015005322 | Biopsy Site Identifier - Revolve |
| 10858015005315 | Biopsy Site Identifier |
| 10858015005308 | Biopsy Site Identifier |
Trademark Results [MammoStar]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MAMMOSTAR 85783036 4364711 Live/Registered |
Devicor Medical Products, Inc. 2012-11-19 |
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