FDA.report

Medline Industries, Inc.

Primary DI
10198459150333
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
DYNJ909805B
Catalog number
DYNJ909805B
Device description
GYN LAPAROSCOPY
Published
2024-10-13
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

Product Codes

CodeName
OHDGynecological laparoscopic kit

Product Code Classifications

CodeDeviceSpecialtyClass
OHDGynecological Laparoscopic KitObstetrics/Gynecology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10198459150333PrimaryGS10

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
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

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
50198956314687CARDINAL HEALTHCardinal Health 200, LLCOHD2026-03-24
50198956374148CARDINAL HEALTHCardinal Health 200, LLCOHD2026-03-24
50198956382433CARDINAL HEALTHCardinal Health 200, LLCOHD2026-03-24
50198956399301CARDINAL HEALTHCardinal Health 200, LLCOHD2026-03-24
50198956418194CARDINAL HEALTHCardinal Health 200, LLCOHD2026-03-24
50198956425581CARDINAL HEALTHCardinal Health 200, LLCOHD2026-03-24
50198956425611CARDINAL HEALTHCardinal Health 200, LLCOHD2026-03-24
50198956258257CARDINAL HEALTHCardinal Health 200, LLCOHD2026-03-23
50198956343243CARDINAL HEALTHCardinal Health 200, LLCOHD2026-03-23
50198956350708CARDINAL HEALTHCardinal Health 200, LLCOHD2026-03-23
50198956353273CARDINAL HEALTHCardinal Health 200, LLCOHD2026-03-23
50198956370270CARDINAL HEALTHCardinal Health 200, LLCOHD2026-03-23
50198956386868CARDINAL HEALTHCardinal Health 200, LLCOHD2026-03-23
50198956389487CARDINAL HEALTHCardinal Health 200, LLCOHD2026-03-23
50198956392401CARDINAL HEALTHCardinal Health 200, LLCOHD2026-03-23
50198956416909CARDINAL HEALTHCardinal Health 200, LLCOHD2026-03-23
50198956419979CARDINAL HEALTHCardinal Health 200, LLCOHD2026-03-23
50198956420555CARDINAL HEALTHCardinal Health 200, LLCOHD2026-03-23
50198956420920CARDINAL HEALTHCardinal Health 200, LLCOHD2026-03-23
50198956431988CARDINAL HEALTHCardinal Health 200, LLCOHD2026-03-23
50198956218763CARDINAL HEALTHCardinal Health 200, LLCOHD2026-03-19
50198956218824CARDINAL HEALTHCardinal Health 200, LLCOHD2026-03-19
50198956259704CARDINAL HEALTHCardinal Health 200, LLCOHD2026-03-19
50198956325362CARDINAL HEALTHCardinal Health 200, LLCOHD2026-03-19
50198956327137CARDINAL HEALTHCardinal Health 200, LLCOHD2026-03-19
50198956334029CARDINAL HEALTHCardinal Health 200, LLCOHD2026-03-19
50198956341607CARDINAL HEALTHCardinal Health 200, LLCOHD2026-03-19
50198956350869CARDINAL HEALTHCardinal Health 200, LLCOHD2026-03-19
50198956364958CARDINAL HEALTHCardinal Health 200, LLCOHD2026-03-19
50198956383010CARDINAL HEALTHCardinal Health 200, LLCOHD2026-03-19