FDA.reportPublic FDA data

ELMED

Primary DI
00198506003820
Brand
ELMED
Company
ELMED INCORPORATED
Model
ST3295802E
Catalog number
ST3295802E
Device description
"LASER BLACK EMMETT HOOKS 9"" OVERALL LENGTH STYLE 2"
Published
2024-04-25
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
HCZForceps, Surgical, Gynecological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HCZForceps, Surgical, GynecologicalObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00198506003820PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00198506003820001985060038201985060038200198506003820

GMDN Terms#

Term, Definition table
TermDefinition
Uterine tenaculumA hand-held manual surgical instrument with hooks at the distal end used for grasping and/or manipulating uterine tissue during a surgical intervention or examination of the uterus and associated structures (e.g., cervix). It typically has a scissors-like, self-retaining design with ring handles and is made of high-grade stainless steel. It is available in various sizes. 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
Serial number
true
Manufacturing date on label
true
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
00198506090899ELMED INCORPORATEDSM13600-10SM13600-102026-05-19
00198506090905ELMED INCORPORATED33370-2733370-272026-05-19
00198506090912ELMED INCORPORATED35-6291435-629142026-05-19
00198506090929ELMED INCORPORATED33761-2133761-212026-05-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840343727567Gen2SURGIX MEDICAL LLCHCZ2026-04-23
00810123209972Adler Instrument CompanyAdler, Inc.HCZ2026-03-03
00198506088834ELMED INCORPORATEDELMED INCORPORATEDHCZ2026-02-25
00198506085420ELMED INCORPORATEDELMED INCORPORATEDHCZ2025-09-09
00198506085437ELMED INCORPORATEDELMED INCORPORATEDHCZ2025-09-09
00198506082962ELMED INCORPORATEDELMED INCORPORATEDHCZ2025-05-22
00198506017797ELMED INCORPORATEDELMED INCORPORATEDHCZ2025-04-11
00198506082054ELMED INCORPORATEDELMED INCORPORATEDHCZ2025-04-11
00198506066016ELMED INCORPORATEDELMED INCORPORATEDHCZ2024-11-12
00198506066023ELMED INCORPORATEDELMED INCORPORATEDHCZ2024-11-12
00198506066078ELMED INCORPORATEDELMED INCORPORATEDHCZ2024-11-12
00198506066085ELMED INCORPORATEDELMED INCORPORATEDHCZ2024-11-12
00198506069758ELMED INCORPORATEDELMED INCORPORATEDHCZ2024-11-12
00198506069802ELMED INCORPORATEDELMED INCORPORATEDHCZ2024-11-12
00198506069819ELMED INCORPORATEDELMED INCORPORATEDHCZ2024-11-12
00198506065828ELMED INCORPORATEDELMED INCORPORATEDHCZ2024-11-01
00198506065835ELMED INCORPORATEDELMED INCORPORATEDHCZ2024-11-01
00198506065842ELMED INCORPORATEDELMED INCORPORATEDHCZ2024-11-01
00198506065859ELMED INCORPORATEDELMED INCORPORATEDHCZ2024-11-01
00198506072840ELMED INCORPORATEDELMED INCORPORATEDHCZ2024-10-28
00198506063077ELMED INCORPORATEDELMED INCORPORATEDHCZ2024-10-16
00198506063145ELMED INCORPORATEDELMED INCORPORATEDHCZ2024-10-16
00198506065453ELMED INCORPORATEDELMED INCORPORATEDHCZ2024-10-16
00198506065613ELMED INCORPORATEDELMED INCORPORATEDHCZ2024-10-16
00198506065620ELMED INCORPORATEDELMED INCORPORATEDHCZ2024-10-16
00198506065811ELMED INCORPORATEDELMED INCORPORATEDHCZ2024-10-16
00198506017568ELMED INCORPORATEDELMED INCORPORATEDHCZ2024-10-03
00840343723408GEN2SURGIX MEDICAL LLCHCZ2024-09-18
00840343723699GEN2SURGIX MEDICAL LLCHCZ2024-09-18
00198506061134ELMED INCORPORATEDELMED INCORPORATEDHCZ2024-09-05