FDA.reportPublic FDA data

Centurion

Primary DI
00653160038316
Brand
Centurion
Company
CENTURION MEDICAL PRODUCTS CORPORATION
Model
BB10M
Catalog number
BB10M
Device description
BREAST BINDER M-SHORT (38'X10')
Published
2022-01-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HEFBINDER, BREAST

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HEFBinder, BreastGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50653160038311PackageGS125In Commercial Distribution
00653160038316PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5065316003831150653160038311
00653160038316006531600383166531600383160653160038316

GMDN Terms#

Term, Definition table
TermDefinition
Breast binder, single-useA fabric wrap intended to be applied to the breast(s) for soft tissue support, typically after surgery; it is not a brassiere (bra). This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(517)546-5400CUSTOMERSERVICE@CENTURIONMP.COM

Regulatory Flags#

DUNS number
017246562
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10653160393757CENTURIONCIT5215ACIT5215A2026-05-27
10653160241010CenturionHGL30HGL302022-01-01
10653160246305CenturionIVS1515IVS15152022-01-01
10653160246589CenturionSV733UDTSV733UDT2022-01-02
10653160250005CenturionHG440XTHG440XT2022-01-01
10653160250234CenturionFCS300FCS3002022-01-01
10653160258063CenturionIV690IV6902022-01-01
10653160262756CenturionANCPR320STANCPR320ST2022-01-01
10653160267270CenturionSV430AFXTSV430AFXT2022-01-02
10653160267294CenturionSV733AFXTSV733AFXT2022-01-02
10653160270164CenturionANC32XT-6ANC32XT-62022-01-01
10653160270171CenturionANC52XT-6ANC52XT-62022-01-01
10653160270201CenturionSCVP44XT-6SCVP44XT-62022-01-02
10653160270218CenturionSCVP66XT-6SCVP66XT-62022-01-02
10653160270256CenturionSV44UXT2-6SV44UXT2-62022-01-02
10653160270263CenturionSV60NXT-6SV60NXT-62022-01-02
10653160270348CenturionSV46VST-6SV46VST-62022-01-02
10653160270386CenturionSV48NFST-6SV48NFST-62022-01-02
10653160270393CenturionSV48VXT-6SV48VXT-62022-01-02
10653160270409CenturionSV80FST-6SV80FST-62022-01-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00817612021053Dale Post Surgical Compression BraDale Medical Products, Inc.HEF2025-03-31
00817612021060Dale Post Surgical Compression BraDale Medical Products, Inc.HEF2025-03-31
00817612021077Dale Post Surgical Compression BraDale Medical Products, Inc.HEF2025-03-31
00817612021084Dale Post Surgical Compression BraDale Medical Products, Inc.HEF2025-03-31
00817612021091Dale Post Surgical Compression BraDale Medical Products, Inc.HEF2025-03-31
00817612020964Dale Post Surgical BraDale Medical Products, Inc.HEF2024-04-25
50653160038311CenturionCENTURION MEDICAL PRODUCTS CORPORATIONHEF2022-01-01
10885380183201CARDINAL HEALTHCardinal Health 200, LLCHEF2021-11-12
10885380183218CARDINAL HEALTHCardinal Health 200, LLCHEF2021-11-12
10885380183225CARDINAL HEALTHCardinal Health 200, LLCHEF2021-11-12
10885380183232CARDINAL HEALTHCardinal Health 200, LLCHEF2021-11-12
10885380183249CARDINAL HEALTHCardinal Health 200, LLCHEF2021-11-12
10885380183256CARDINAL HEALTHCardinal Health 200, LLCHEF2021-11-12
10885380183263CARDINAL HEALTHCardinal Health 200, LLCHEF2021-11-12
10885380183270CARDINAL HEALTHCardinal Health 200, LLCHEF2021-11-12
10885380183287CARDINAL HEALTHCardinal Health 200, LLCHEF2021-11-12
10885380183294CARDINAL HEALTHCardinal Health 200, LLCHEF2021-11-12
10885380183317CARDINAL HEALTHCardinal Health 200, LLCHEF2021-11-12
10885380183324CARDINAL HEALTHCardinal Health 200, LLCHEF2021-11-12
10885380183331CARDINAL HEALTHCardinal Health 200, LLCHEF2021-11-12
00082161080053NuRooBROWNMED, INC.HEF2020-08-13
00082161080060NuRooBROWNMED, INC.HEF2020-08-13
00082161080077NuRooBROWNMED, INC.HEF2020-08-13
00082161080084NuRooBROWNMED, INC.HEF2020-08-13
00849174080001NuRooBROWNMED, INC.HEF2020-08-13
00849174080308NuRooBROWNMED, INC.HEF2020-08-13
00817612020452Dale Post Surgical BraDale Medical Products, Inc.HEF2019-06-24
00817612020469Dale Post Surgical BraDale Medical Products, Inc.HEF2019-06-24
00817612020476Dale Post Surgical BraDale Medical Products, Inc.HEF2019-06-24
00817612020483Dale Post Surgical BraDale Medical Products, Inc.HEF2019-06-24