FDA.report

MEDLINE

Primary DI
20193489198765
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
DYNDH1580
Catalog number
DYNDH1580
Device description
CT BIOPSY TRAY
Published
2020-11-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
OFGCT biopsy tray

Product Code Classifications

CodeDeviceSpecialtyClass
OFGCt Biopsy TrayCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20193489198765PackageGS120In Commercial Distribution
10193489198768PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2019348919876520193489198765
1019348919876810193489198768

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
+1(800)633-5463CUSTOMERSERVICE@MEDLINE.COM

Regulatory Flags

DUNS number
025460908
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
true
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
true
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
10080196163885MEDLINENONTH100BNONTH100B2026-03-24
10884389110003MEDLINECRI5001BCRI5001B2026-03-24
10884389110010MEDLINECRI5000BCRI5000B2026-03-24
10884389110072MEDLINENONTH200BNONTH200B2026-03-24
30193489036224MEDLINEMDSE2RDCAMDSE2RDCA2022-12-10
30193489036248MEDLINEMDSE2RDCPMDSE2RDCP2022-12-10
30193489036262MEDLINEMDSE2X2CAMDSE2X2CA2022-12-10
40888277170897MEDLINEFG1501FG15012026-03-20
40888277170972MEDLINEFG1503FG15032026-03-20
40888277358455MEDLINEMPHPN315MPHPN3152026-03-19
40888277358462MEDLINEMPHPN318MPHPN3182026-03-19
20197344009807HUDSON RCIHUD2417HUD24172026-03-19
20080196286789MEDLINEMDT2168282MDT21682822016-10-14
20080196765574MEDLINE INDUSTRIES, INC.NONLV200NONLV2002025-05-28
10197344010264HUDSON RCIHUD1846HUD18462026-03-19
20884389108199MEDLINE INDUSTRIES, INC.NONLV200XXXLNONLV200XXXL2024-03-05
20884389108229MEDLINENONLV200XXLNONLV200XXL2025-05-27
20884389155360MEDLINENONLV240NONLV2402025-05-27
20884389155377MEDLINENONLV240XLNONLV240XL2025-05-27
20888277336893MEDLINENON50240NON502402025-05-27

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
50198956320718CARDINAL HEALTHCardinal Health 200, LLCOFG2026-03-16
50198956364156CARDINAL HEALTHCardinal Health 200, LLCOFG2026-03-16
50198956401479CARDINAL HEALTHCardinal Health 200, LLCOFG2026-03-10
50198956323009CARDINAL HEALTHCardinal Health 200, LLCOFG2026-03-02
50198956336610CARDINAL HEALTHCardinal Health 200, LLCOFG2026-02-20
00191072241696ACSAMERICAN CONTRACT SYSTEMS, INC.OFG2026-02-02
50198956337266CARDINAL HEALTHCardinal Health 200, LLCOFG2026-01-26
00191072241559ACSAMERICAN CONTRACT SYSTEMS, INC.OFG2026-01-14
50198956203936CARDINAL HEALTHCardinal Health 200, LLCOFG2025-12-17
50198956267846CARDINAL HEALTHCardinal Health 200, LLCOFG2025-11-17
00191072239570ACSAMERICAN CONTRACT SYSTEMS, INC.OFG2025-09-29
50198956197440CARDINAL HEALTHCardinal Health 200, LLCOFG2025-09-22
50198956199987CARDINAL HEALTHCardinal Health 200, LLCOFG2025-09-19
50198956181364CARDINAL HEALTHCardinal Health 200, LLCOFG2025-08-27
40198459470760MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFG2025-08-18
40198459474836MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFG2025-08-18
40198459480233MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFG2025-08-18
40198459481247MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFG2025-08-18
40198459485092MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFG2025-08-18
40198459450489MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFG2025-08-11
40198459453695MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFG2025-08-11
40198459453701MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFG2025-08-11
40198459453725MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFG2025-08-11
40198459453770MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFG2025-08-11
40198459453787MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFG2025-08-11
40198459453794MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFG2025-08-11
40198459453923MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFG2025-08-11
40198459461690MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFG2025-08-11
40198459462994MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFG2025-08-11
40198459464738MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFG2025-08-11