FDA.report

Medline Industries, Inc.

Primary DI
10193489754698
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
128733
Catalog number
128733
Device description
RAPID DEPLOYMENT 10FR 6PK
Published
2019-07-28
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

Related Records

Contact Domains

Product Codes

CodeName
KGSRETENTION DEVICE, SUTURE

Product Code Classifications

CodeDeviceSpecialtyClass
KGSRetention Device, SutureGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
40193489754699PackageGS113In Commercial Distribution
10193489754698PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
4019348975469940193489754699
1019348975469810193489754698

GMDN Terms

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

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
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
false
Sterilization required before use
false

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20080196286789MEDLINEMDT2168282MDT21682822016-10-14
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10197344010264HUDSON RCIHUD1846HUD18462026-03-19
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20884389108229MEDLINENONLV200XXLNONLV200XXL2025-05-27
20884389155360MEDLINENONLV240NONLV2402025-05-27
20884389155377MEDLINENONLV240XLNONLV240XL2025-05-27
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Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
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00810178880669ViveVIVE HEALTH LLCKGS2026-02-05
10850012846687SVELTEFELT™ QUICK PLEDGE™LSI Solutions, Inc.KGS2026-01-21
00851424007157LockeT Suture Retention DeviceCatheter Precision, Inc.KGS2026-01-13
20888277381763MEDLINEMEDLINE INDUSTRIES, INC.KGS2025-01-03
00884450786192Perchik Button™Merit Medical Systems, Inc.KGS2024-07-02
10860011629402Q-StopDRS Vascular, Inc.KGS2024-05-23
10630094199815Bioseal Inc.BIOSEALKGS2023-12-19
10630094199839Bioseal Inc.BIOSEALKGS2023-12-19
10630094199860Bioseal Inc.BIOSEALKGS2023-12-19
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