FDA.reportPublic FDA data

Medline Industries, Inc.

Primary DI
10193489591675
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
SAMPC0529
Catalog number
SAMPC0529
Device description
CSTM RADIAL FEM PACK
Published
2019-01-27
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PUIDrape, surgical, exempt

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PUIDrape, Surgical, ExemptGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10193489591675PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1019348959167510193489591675

GMDN Terms#

Term, Definition table
TermDefinition
General/plastic surgical procedure kit, non-medicated, single-useA collection of various surgical instruments, sometimes with dressings and/or other materials, intended to be used to: 1) assist a range of surgical procedures across multiple clinical specialities typically as a general-purpose tray; or 2) assist with a plastic surgery procedure. It does not contain pharmaceuticals. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
025460908
Device count
1
DM exempt
true
Premarket exempt
true
Kit
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10080196180639GeminiGEM1115SGEM1115S2020-12-22
00080196749884MEDLINEMDS149010MDS1490102024-03-05
00080196749891MEDLINEMDS149000MDS1490002021-09-09
10080196418329MEDLINEHCS4482RHCS4482R2021-03-31
10080196418336MEDLINEHCS4483RHCS4483R2020-12-01
10080196715534HUDSON RCIHCS4482HCS44822021-03-31
10080196715565MEDLINEHCS4486HCS44862021-03-31
10888277657625MEDLINEHCSU4483HCSU44832021-10-01
10888277699205MEDLINEHCS4481VTHCS4481VT2021-10-01
10888277699229MEDLINEHCS4483VTHCS4483VT2021-10-01
10888277699236MEDLINE INDUSTRIESHCSU448314HCSU4483142021-10-01
00888277692100MEDLINEHCS4480HCS44802021-05-18
00888277699215MEDLINEHCS448314HCS4483142021-05-18
10080196715541MEDLINEHCS4483HCS44832020-10-28
00888277682033MEDLINEHCSU4482HCSU44822020-08-21
00888277682040MEDLINEHCSU4485HCSU44852020-08-21
10080196259441MedlineMDT013380MDT0133802016-10-14
10080196993819MEDLINEDYND19120DYND191202020-11-12
00080196515939CURADCUR9224CUR92242026-07-06
10197344012039HUDSON RCIHUD1743HUD17432026-07-06

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06932523052430Equipment DrapeJiangSu MedPlus Non-Woven Manufacturer Co., LtdPUI2026-07-08
10304040193362Henry ScheinHENRY SCHEIN, INC.PUI2026-06-25
00748426263448Convertors®Microtek Medical LLCPUI2026-06-09
30680651501272HalyardO&M HALYARD, INC.PUI2026-06-08
30680651501289HalyardO&M HALYARD, INC.PUI2026-06-08
30680651501296HalyardO&M HALYARD, INC.PUI2026-06-08
30680651501302HalyardO&M HALYARD, INC.PUI2026-06-08
16931918100876AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
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16931918139449AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918179179AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
30680651424465HalyardO&M HALYARD, INC.PUI2026-06-02
50192253071595CONVERTORSCardinal Health 200, LLCPUI2026-06-02
50192253071601CONVERTORSCardinal Health 200, LLCPUI2026-06-02