FDA.reportPublic FDA data

Medline Industries, Inc.

Primary DI
10193489466119
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
DYNJ0405997N
Catalog number
DYNJ0405997N
Device description
GYN LAPAROSCOPY PACK-LF
Published
2021-08-27
Public version status
Update
Distribution status
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
OHDGynecological laparoscopic kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OHDGynecological Laparoscopic KitObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40193489466110PackageGS13In Commercial Distribution
10193489466119PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4019348946611040193489466110
1019348946611910193489466119

GMDN Terms#

Term, Definition table
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.

Contacts#

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

Regulatory Flags#

DUNS number
025460908
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10888277417205MEDLINEMSG9460MSG94602026-08-03
10888277417212MEDLINEMSG9465MSG94652026-08-03
10888277417229MEDLINEMSG9470MSG94702026-08-03
10888277417236MEDLINEMSG9475MSG94752026-08-03
10888277417243MEDLINEMSG9480MSG94802026-08-03
10888277417250MEDLINEMSG9485MSG94852026-08-03
10888277417267MEDLINEMSG9490MSG94902026-08-03
10888277603516MEDLINEMSG9590MSG95902026-08-03
20197344102898GeminiGEM3120CGEM3120C2024-08-02
20197344102904GeminiGEM3120SCGEM3120SC2024-07-15
10080196184125GeminiGEM3120SGEM3120S2016-10-14
10080196184286MEDLINEGEM3130SGEM3130S2016-10-14
10197344169405MEDLINEMSCSRG9636MSCSRG96362026-07-31
10198459678653MEDLINEURO175806PSURO175806PS2026-07-31
10198459678660MEDLINEURO175808PSURO175808PS2026-07-31
10198459678677MEDLINEURO175806SURO175806S2026-07-31
10198459678684MEDLINEURO175808SURO175808S2026-07-31
10198459678691MEDLINEURO175810SURO175810S2026-07-31
10198459679025MEDLINEURO175810PSURO175810PS2026-07-31
20197344219237MEDLINENON27393NON273932026-07-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160528334HALYARDAVID MEDICAL, INC.OHD2026-08-01
10198956368125CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-31
10198956393295CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-31
10198956460669CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-31
10198956475281CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-31
10198956500174CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-31
10198956503052CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-31
10198956505322CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-31
10198956513822CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-31
10198956516823CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-31
10198956523326CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-31
10198956538481CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-31
10198956538580CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-31
10198956543027CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-31
10198956196261CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-27
10198956385573CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-27
10198956392410CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-27
10198956446632CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-27
10198956448186CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-27
10198956460676CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-27
10198956469242CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-27
10198956475182CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-27
10198956485297CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-27
10198956497726CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-27
10198956502727CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-27
10198956505926CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-27
10198956507173CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-27
10198956513044CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-27
10198956513983CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-27
10198956516267CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-27