FDA.reportPublic FDA data

Medline

Primary DI
40888277002631
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
SPEC0117B
Catalog number
SPEC0117B
Device description
BIOPSY PACK
Published
2016-10-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OFGCT biopsy tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OFGCt Biopsy TrayCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40888277002631PackageGS122In Commercial Distribution
10888277002630PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4088827700263140888277002631
1088827700263010888277002630

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, non-medicated, reusableA general-purpose collection of various sterile surgical instruments, dressings, and materials intended to be used to assist a range of surgical procedures across multiple clinical specialities. It does not contain pharmaceuticals. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags#

DUNS number
025460908
Device count
1
DM exempt
true
Premarket exempt
true
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10653160393306MEDLINEDYND74299DYND742992026-05-26
10080196031214MEDLINEDYND13515DYND135152021-02-19
10080196032143MEDLINEDYND30331DYND303312022-03-29
10080196137695MEDLINEDYND30351DYND303512021-11-02
10080196158522MEDLINEMDS138000MDS1380002021-05-14
10080196258598MEDLINEMDT013020457MDT0130204572016-10-14
10080196260126MEDLINEMDT013628MDT0136282016-10-14
10080196363773MEDLINEMDT013667MDT0136672016-10-14
10080196363803MEDLINEMDT013673FMDT013673F2016-10-14
10197344039746MEDLINEHNX19100HNX191002024-10-11
10197344039784MEDLINEHNX20150HNX201502024-10-11
10197344039838MEDLINEHNY19100HNY191002024-10-11
10197344039845MEDLINEHNY19150HNY191502024-10-11
10197344039852MEDLINEHNY20075HNY200752024-10-11
10197344039869MEDLINEHNY20100HNY201002024-10-11
10197344039876MEDLINEHNY20150HNY201502024-10-11
10197344039883MEDLINEHNY22075HNY220752024-10-11
10197344039890MEDLINEHNY22100HNY221002024-10-11
10197344039906MEDLINEHNY22150HNY221502024-09-27
10197344099771MEDLINEAVT0665AVT06652025-03-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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