FDA.reportPublic FDA data

ELMED

Primary DI
00842180130579
Brand
ELMED
Company
ELMED INCORPORATED
Model
52224-27B
Catalog number
52224-27B
Device description
5MM DIA., 24CM, ENDO CLINCH FENESTRATED GRASPER, INSULATED SHAFT & HANDLE W/RF-POST, ROTATABLE-ONE PIECE W/FLUSHPORT
Published
2018-06-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GCJLaparoscope, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842180130579PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842180130579008421801305798421801305790842180130579

GMDN Terms#

Term, Definition table
TermDefinition
Laparoscope system, reusableAn assembly of laparoscopes and their accessories used for the visual examination and treatment of the abdominal/retroperitoneal cavity and its organs (laparoscopy). The insertion is typically through an incision(s) made in the abdominal wall (routinely just below the umbilicus or in the near vicinity). This system is mostly used for gynaecological procedures involving the evaluation/treatment of abdominal or pelvic pain, ectopic pregnancy, ovarian cysts, appendicitis, or for female sterilization. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
224-353-6446medical@elmed.com

Regulatory Flags#

DUNS number
049290364
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00198506039072ELMED INCORPORATEDST5240905ST52409052026-07-17
00198506092107ELMED INCORPORATEDST233061ST2330612026-07-17
00198506092114ELMED INCORPORATEDST233064ST2330642026-07-17
00198506092121ELMED INCORPORATEDST233065ST2330652026-07-17
00198506092152ELMED INCORPORATEDST1976718ST19767182026-07-17
00198506092176ELMED INCORPORATEDST5220340ST52203402026-07-17
00198506092190ELMED INCORPORATEDST5243000HST5243000H2026-07-17
00198506092206ELMED INCORPORATEDST5243004HST5243004H2026-07-17
00198506092213ELMED INCORPORATEDST5243005HST5243005H2026-07-17
00198506092220ELMED INCORPORATEDST5246000HST5246000H2026-07-17
00198506092237ELMED INCORPORATEDST5246003HST5246003H2026-07-17
00198506092244ELMED INCORPORATEDST5246004HST5246004H2026-07-17
00198506092251ELMED INCORPORATEDST5246005HST5246005H2026-07-17
00198506092268ELMED INCORPORATEDST5246006HST5246006H2026-07-17
00198506092275ELMED INCORPORATEDST5240900ST52409002026-07-17
00198506092282ELMED INCORPORATEDST5240901ST52409012026-07-17
00198506092299ELMED INCORPORATEDST5240904ST52409042026-07-17
00198506092305ELMED INCORPORATEDST5241200ST52412002026-07-17
00198506092312ELMED INCORPORATEDST5241201ST52412012026-07-17
00198506092329ELMED INCORPORATEDST5241202ST52412022026-07-17

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506092176ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-07-17
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B382SD90781001000Surgical DirectSurgical Direct, Inc.GCJ2026-07-17
B382SD9918100Surgical DirectSurgical Direct, Inc.GCJ2026-07-17
B382SD1184590Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD12711090Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD1271390Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD1271590Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD13018770Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD13168350Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD23373490Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD770561050Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD775011530Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD775021630Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD77505650Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD7751586C0Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD7751587C0Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
00850045863012ArthroFree® 2 ReceiverLazurite Holdings LLCGCJ2026-07-10
00850045863029ArthroFree® 2 Wireless Camera HeadLazurite Holdings LLCGCJ2026-07-10
00850045863036ArthroFree® 2 Operating Room KitLazurite Holdings LLCGCJ2026-07-10
00850045863043ArthroFree® 2 Single Camera Head SetLazurite Holdings LLCGCJ2026-07-10
B382SD883110450Surgical DirectSurgical Direct, Inc.GCJ2026-07-10
B382SD88324450Surgical DirectSurgical Direct, Inc.GCJ2026-07-10
00190776421731MillenniumAvalign Technologies, Inc.GCJ2026-06-24
00190776421663MillenniumAvalign Technologies, Inc.GCJ2026-06-23
00190776421687MillenniumAvalign Technologies, Inc.GCJ2026-06-23
00198506091506ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-06-10
00198506044366ELMEDELMED INCORPORATEDGCJ2026-06-09
00812231033906PixaSANTA BARBARA IMAGING SYSTEMS, INC.GCJ2026-06-08
00812231033913PixaSANTA BARBARA IMAGING SYSTEMS, INC.GCJ2026-06-08