MammoStar™ STAR0831
GUDID 10858015005322
Biopsy Site Identifier - Revolve
Carbon Medical Technologies, Inc.
Imaging lesion localization marker, implantable| Primary Device ID | 10858015005322 |
| NIH Device Record Key | c31cb0e9-8805-4140-befa-71f91d14e178 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MammoStar™ |
| Version Model Number | STAR0831 |
| Catalog Number | STAR0831 |
| 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 | 17 Millimeter |
| Outer Diameter | 2 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 17 Millimeter |
| Outer Diameter | 2 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 17 Millimeter |
| Outer Diameter | 2 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 17 Millimeter |
| Outer Diameter | 2 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 17 Millimeter |
| Outer Diameter | 2 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 17 Millimeter |
| Outer Diameter | 2 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 17 Millimeter |
| Outer Diameter | 2 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 17 Millimeter |
| Outer Diameter | 2 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 17 Millimeter |
| Outer Diameter | 2 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 17 Millimeter |
| Outer Diameter | 2 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 17 Millimeter |
| Outer Diameter | 2 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 17 Millimeter |
| Outer Diameter | 2 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 17 Millimeter |
| Outer Diameter | 2 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 17 Millimeter |
| Outer Diameter | 2 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 17 Millimeter |
| Outer Diameter | 2 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 17 Millimeter |
| Outer Diameter | 2 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 17 Millimeter |
| Outer Diameter | 2 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 17 Millimeter |
| Outer Diameter | 2 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 17 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 | 00858015005325 [Primary] |
| GS1 | 10858015005322 [Package] Contains: 00858015005325 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 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.