FDA.report

Sterling Medical Products

Primary DI
10685404000657
Brand
Sterling Medical Products
Company
APOLLO MEDICAL PRODUCTS CORP.
Model
BC-011C
Device description
ULTRASOUND BIOPSY TRAY
Published
2019-08-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10685404000657PackageGS120In Commercial Distribution
00685404000650PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1068540400065710685404000657
00685404000650006854040006506854040006500685404000650

GMDN Terms

TermDefinition
Soft-tissue biopsy procedure kit, medicatedA collection of sterile devices, which includes a pharmaceutical(s), designed to perform a non-specific soft tissue biopsy (e.g., skin biopsy, breast biopsy); it is not dedicated to biopsy of a specific internal organ. It includes the biopsy needle used for this procedure. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
815-537-5303andrea@sterlingmedproducts.com

Regulatory Flags

DUNS number
116768422
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
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

Other Devices From This Company

Primary DIBrandModelCatalogPublished
10685404001913Sterling Medical ProductsLK22102020-05-20
10685404001951Sterling Medical ProductsLK22152020-05-20
10685404002842Sterling Medical ProductsQ100252024-06-07
10685404003115Sterling Medical ProductsQ100242024-06-07
10685404003269Sterling Medical Products1000232024-06-07
10685404003276Sterling Medical Products1000402024-06-07
10685404003283Sterling Medical Products1000252024-06-07
10685404003290Sterling Medical Products1000172024-06-07
10685404003306Sterling Medical Products1000412024-06-07
10685404003313Sterling Medical ProductsEA-L30012024-06-07
10685404003337Sterling Medical Products99-10-14502024-06-07
10685404003344Sterling Medical Products99-10-17402024-06-07
10685404003351Sterling Medical Products2712024-06-07
10685404003368Sterling Medical Products1000122024-06-07
10685404003375Sterling Medical Products1000222024-06-07
10685404003382Sterling Medical Products1000072024-06-07
10685404003399Sterling Medical Products1000322024-06-07
10685404003405Sterling Medical ProductsAU-L1013-502024-06-07
10685404003412Sterling Medical Products9447062024-06-07
10685404003429Sterling Medical Products9447072024-06-07