FDA.reportPublic FDA data

Medichoice

Primary DI
10885632126413
Brand
Medichoice
Company
OWENS & MINOR DISTRIBUTION, INC.
Model
STB651
Device description
X Rx Tray Biopsy Soft-Tissue Basic Single-Patient Use Latex-Free Sterile MediChoice
Published
2016-08-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FCHTRAY, BIOPSY, WITHOUT BIOPSY INSTRUMENTS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FCHTray, Biopsy, Without Biopsy InstrumentsGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50885632126411PackageGS110In Commercial Distribution
10885632126413PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088563212641150885632126411
1088563212641310885632126413

GMDN Terms#

Term, Definition table
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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature68 Degrees Fahrenheit77 Degrees Fahrenheit
Special Storage Condition, Specify00
Special Storage Condition, Specify00Avoid freezing and excessive heat

Regulatory Flags#

DUNS number
007941230
Device count
1
Premarket exempt
true
Kit
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
10885632541131SurgiTrackSM45005945612026-10-22
10885632417122Halyard555702026-10-21
10885632417146Halyard555722026-10-21
10885632520327HALYARDABC10102026-10-21
10885632520334HALYARDABC10122026-10-21
20885632532129HALYARDABCP10062026-10-21
10885632540776SurgiTrackSM450387ABDC2026-10-19
10885632540844SurgiTrackSM45016406752026-10-19
10885632540851SurgiTrackSM450164E9E92026-10-19
10885632540639SurgiTrackSM450030A8C42026-10-15
10885632540646SurgiTrackSM450030D0722026-10-15
10885632540615SurgiTrackSM450087ABBD2026-10-13
10885632540059SurgiTrackSM4503872A3B2026-10-07
10885632539206SurgiTrackSM450041D1852026-09-29
10885632539039SurgiTrackSM450087473B2026-09-25
10885632538902SurgiTrackSM450048BAEE2026-09-24
10885632537066SurgiTrackSM4501483A7F2026-09-18
10885632537110SurgiTrackSM450070CC682026-09-18
10885632532665SurgiTrackSM450087F5342026-09-04
10885632532726SurgiTrackSM450041DB622026-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M78312011160Diversatek HealthcareDIVERSATEK HEALTHCARE, INC.FCH2025-11-14
M78312011161Diversatek HealthcareDIVERSATEK HEALTHCARE, INC.FCH2025-11-14
00810185250363TherapakTherapak LLCFCH2025-08-11
00810185250387TherapakTherapak LLCFCH2025-08-11
00810185250424TherapakTherapak LLCFCH2025-08-11
00810185250448TherapakTherapak LLCFCH2025-08-11
00810185250523TherapakTherapak LLCFCH2025-08-11
00810185250370TherapakTherapak LLCFCH2025-08-11
00810185250431TherapakTherapak LLCFCH2025-08-11
00810185250455TherapakTherapak LLCFCH2025-08-11
00810185250530TherapakTherapak LLCFCH2025-08-11
00810185250400TherapakTherapak LLCFCH2025-08-04
00810185250394TherapakTherapak LLCFCH2025-08-04
10809160472033HalyardAVID MEDICAL, INC.FCH2025-07-02
20809160472030HalyardAVID MEDICAL, INC.FCH2025-07-02
M78312011150Diversatek HealthcareDIVERSATEK HEALTHCARE, INC.FCH2025-06-30
00191072239426ACSAMERICAN CONTRACT SYSTEMS, INC.FCH2025-05-27
M78312011130Diversatek HealthcareDIVERSATEK HEALTHCARE, INC.FCH2025-04-03
M78312011120Diversatek HealthcareDIVERSATEK HEALTHCARE, INC.FCH2025-02-28
00191072236067ACSAMERICAN CONTRACT SYSTEMS, INC.FCH2025-01-31
00191072236098ACSAMERICAN CONTRACT SYSTEMS, INC.FCH2025-01-31
00191072233714ACSAMERICAN CONTRACT SYSTEMS, INC.FCH2024-12-19
M78312011100Diversatek HealthcareDIVERSATEK HEALTHCARE, INC.FCH2024-10-31
M78312011101Diversatek HealthcareDIVERSATEK HEALTHCARE, INC.FCH2024-10-31
00191072231376ACSAMERICAN CONTRACT SYSTEMS, INC.FCH2024-10-21
00191072230935ACSAMERICAN CONTRACT SYSTEMS, INC.FCH2024-10-14
M78312011080Diversatek HealthcareDIVERSATEK HEALTHCARE, INC.FCH2024-06-07
M78312011081Diversatek HealthcareDIVERSATEK HEALTHCARE, INC.FCH2024-06-07
00191072223982ACSAMERICAN CONTRACT SYSTEMS, INC.FCH2024-05-08
00191072223999ACSAMERICAN CONTRACT SYSTEMS, INC.FCH2024-05-08