FDA.report

Medline Industries, Inc.

Primary DI
40195327057665
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
DNSC97175
Catalog number
DNSC97175
Device description
BAG BAND DOME 40IN 100/CS
Published
2022-08-04
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
MMPCover, barrier, protective

Product Code Classifications

CodeDeviceSpecialtyClass
MMPCover, Barrier, ProtectiveGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
40195327057665PackageGS1100In Commercial Distribution
10195327057664PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
4019532705766540195327057665
1019532705766410195327057664

GMDN Terms

TermDefinition
General surgical procedure kit, non-medicated, single-useA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. 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
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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30193489036248MEDLINEMDSE2RDCPMDSE2RDCP2022-12-10
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20080196286789MEDLINEMDT2168282MDT21682822016-10-14
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20884389108229MEDLINENONLV200XXLNONLV200XXL2025-05-27
20884389155360MEDLINENONLV240NONLV2402025-05-27
20884389155377MEDLINENONLV240XLNONLV240XL2025-05-27
20888277336893MEDLINENON50240NON502402025-05-27

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00814707023817ProtekASPEN SURGICAL PRODUCTS, INC.MMP2026-02-16
00850061871053IMAGE DIAGNOSTICS INCIMAGE DIAGNOSTICS, INC.MMP2024-10-23
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40193489130226COLABELMEDLINE INDUSTRIES, INC.MMP2024-04-11
40884389413631Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2023-10-01
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40884389614601Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2023-10-01
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40193489771474Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2022-08-04
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20888277677972MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.MMP2021-01-29
40080196073161MedlineMEDLINE INDUSTRIES, INC.MMP2020-12-31
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