FDA.reportPublic FDA data

ELMED

Primary DI
00842180184350
Brand
ELMED
Company
ELMED INCORPORATED
Model
23-1763-STRYKER
Catalog number
23-1763-STRYKER
Device description
3.2MM CANNULA, STRYKER SPEED LOCK STYLE, DUAL ROTATING STOPCOCKS
Published
2024-01-18
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
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
NWVLaparoscopic Accessories, Gynecologic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NWVLaparoscopic Accessories, GynecologicObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842180184350PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842180184350008421801843508421801843500842180184350

GMDN Terms#

Term, Definition table
TermDefinition
Laparoscopic surgical procedure kit, non-medicated, reusableA collection of various laparoscopic and surgical instruments (e.g., access cannulae, irrigation/aspiration cannula, forceps), dressings, and additional materials intended to be used specifically to perform a laparoscopic surgical procedure. It does not contain pharmaceuticals. It may be referred to as a procedure tray. 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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00198506090967ELMED INCORPORATED37120-3537120-352026-05-26
00198506090974ELMED INCORPORATEDSTE36101ESTE36101E2026-05-26
00198506090981ELMED INCORPORATEDSTE3641ESTE3641E2026-05-26
00198506090998ELMED INCORPORATEDSTE245013STE2450132026-05-26
00198506091001ELMED INCORPORATEDSTE245014STE2450142026-05-26
00198506091018ELMED INCORPORATEDSTE245015STE2450152026-05-26
00198506091025ELMED INCORPORATEDSTE245016STE2450162026-05-26
00198506091032ELMED INCORPORATEDSTE245017STE2450172026-05-26
00198506091049ELMED INCORPORATEDSTE245018STE2450182026-05-26
00198506091056ELMED INCORPORATEDSTE245019STE2450192026-05-26
00198506091063ELMED INCORPORATEDSTE245020STE2450202026-05-26
00198506091070ELMED INCORPORATEDSTE245021STE2450212026-05-26
00198506091087ELMED INCORPORATEDSTE245022STE2450222026-05-26
00198506091100ELMED INCORPORATEDSTE322924ISTE322924I2026-05-26
00198506091117ELMED INCORPORATEDSTE322923ISTE322923I2026-05-26
00198506091124ELMED INCORPORATEDSTE3211221ESTE3211221E2026-05-26
00198506089763ELMED INCORPORATED52460-01-H52460-01-H2026-03-24
00198506089770ELMED INCORPORATED52460-02-H52460-02-H2026-03-24
00198506089787ELMED INCORPORATED52460-03-H52460-03-H2026-03-24
00198506089756ELMED INCORPORATED42-191042-19102026-03-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00848657078269AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.NWV2026-03-02
00190776417390MillenniumAvalign Technologies, Inc.NWV2026-02-27
00190776417406MillenniumAvalign Technologies, Inc.NWV2026-02-27
00190776417451MillenniumAvalign Technologies, Inc.NWV2026-02-27
00198506088520ELMED INCORPORATEDELMED INCORPORATEDNWV2026-02-23
00190776416072MillenniumAvalign Technologies, Inc.NWV2026-02-06
00190776415631MillenniumAvalign Technologies, Inc.NWV2026-02-02
00190776415648MillenniumAvalign Technologies, Inc.NWV2026-02-02
00190776415655MillenniumAvalign Technologies, Inc.NWV2026-02-02
00190776415402MillenniumAvalign Technologies, Inc.NWV2026-01-27
00848657078108AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.NWV2026-01-15
00848657078115AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.NWV2026-01-15
00848657078122AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.NWV2026-01-15
00848657077958AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.NWV2026-01-13
00848657077965AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.NWV2026-01-13
00848657078009AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.NWV2026-01-13
00190776411275MillenniumAvalign Technologies, Inc.NWV2025-09-22
00860003326404AbGrabLapovations, LLCNWV2025-07-25
00190776402440MillenniumAvalign Technologies, Inc.NWV2025-06-23
00190776401733MillenniumAvalign Technologies, Inc.NWV2025-06-12
00190776396107MillenniumAvalign Technologies, Inc.NWV2025-05-09
00190776394936MillenniumAvalign Technologies, Inc.NWV2025-05-08
08904332600513MediflexENDOSYS HEALTHCARE INDIA PRIVATE LIMITEDNWV2025-03-10
00198506045370ELMED INCORPORATEDELMED INCORPORATEDNWV2024-12-19
00198506073854ELMED INCORPORATEDELMED INCORPORATEDNWV2024-12-19
00190776389956MillenniumAvalign Technologies, Inc.NWV2024-11-18
00190776389109MillenniumAvalign Technologies, Inc.NWV2024-11-14
00198506017650ELMED INCORPORATEDELMED INCORPORATEDNWV2024-10-25
04547410515893FUJIFILMFUJIFILM CORPORATIONNWV2024-10-04
04547410524284FUJIFILMFUJIFILM CORPORATIONNWV2024-10-04