FDA.reportPublic FDA data

Medline

Primary DI
20193489082538
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
PAD9165
Catalog number
PAD9165
Device description
PAD, GROUNDING, UNIVERSAL, SPLIT, 9'
Published
2023-06-08
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEIElectrosurgical, cutting & coagulation & accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K212093000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212093000Medline Universal Grounding PadMedline Industries, Inc.2022-01-14GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20193489082538PackageGS140In Commercial Distribution
10193489082531PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2019348908253820193489082538
1019348908253110193489082531

GMDN Terms#

Term, Definition table
TermDefinition
Electrosurgical return electrode, single-useA dispersive conductor intended to be fastened to a patient and connected to an electrosurgical/radio-frequency ablation system generator, to allow return of electrical current from the patient to the generator during an electrosurgical procedure. It has a large surface area and is fastened to the patient's body typically where the greatest surface area can be covered in closest proximity to the surgical site. It will typically be designed with permanently attached leads. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Handle with Care
Special Storage Condition, Specify00Store product away from direct exposure to light at room temperature.
Storage Environment Temperature20 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
025460908
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
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
true
Sterilization required before use
false

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
00190776408718MillenniumAvalign Technologies, Inc.GEI2026-08-03
00190776422677MillenniumAvalign Technologies, Inc.GEI2026-08-03
00190776422820MillenniumAvalign Technologies, Inc.GEI2026-08-03
B382SD5657815600Surgical DirectSurgical Direct, Inc.GEI2026-08-03
00190776407445MillenniumAvalign Technologies, Inc.GEI2026-07-31
00190776422332MillenniumAvalign Technologies, Inc.GEI2026-07-31
00190776422516MillenniumAvalign Technologies, Inc.GEI2026-07-31
00198506092640ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-29
00198506093562ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-29
07613327688849MalisSTRYKER CORPORATIONGEI2026-07-29
07613327688856MalisSTRYKER CORPORATIONGEI2026-07-29
07613327688979MalisSTRYKER CORPORATIONGEI2026-07-29
07613327688986MalisSTRYKER CORPORATIONGEI2026-07-29
08800020110688INTRAGen HandpieceJeisys Medical Inc.GEI2026-07-29
B354OSRP80Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGEI2026-07-29
B354OSRP81Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGEI2026-07-29
B354OSRP82Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGEI2026-07-29
B354OSRP83Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGEI2026-07-29
B354OSRP84Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGEI2026-07-29
B354OSRP85Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGEI2026-07-29
B354OSRP89Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGEI2026-07-29
00190776407285MillenniumAvalign Technologies, Inc.GEI2026-07-28
00190776407292MillenniumAvalign Technologies, Inc.GEI2026-07-28
00198506092770ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-28
00198506092886ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-28
00198506092893ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-28
00198506092909ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-28
00198506092916ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-28
00198506092954ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-28
00198506092961ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-28