FDA.report

ELMED

Primary DI
00198506003301
Brand
ELMED
Company
ELMED INCORPORATED
Model
ST3193733
Catalog number
ST3193733
Device description
HYSTEROSCOPY ALLIGATOR GRASPING FORCEPS, SEMI RIGID, 9 FRENCH, 370MM
Published
2024-04-24
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

Related Records

Contact Domains

Product Codes

CodeName
NWWHysteroscope Accessories

Product Code Classifications

CodeDeviceSpecialtyClass
NWWHysteroscope AccessoriesObstetrics/Gynecology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00198506003301PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00198506003301001985060033011985060033010198506003301

GMDN Terms

TermDefinition
Flexible endoscopic tissue manipulation forceps, reusableA flexible, hand-held manual surgical instrument designed to be introduced through the working channel of an endoscope to grasp tissue (typically atraumatically), or additionally foreign bodies. It has proximal controls (e.g., scissors-like handles), a flexible long slender shaft, and distal grasping jaws; it is not an electrosurgical device and is not dedicated to biopsy. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

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 DIBrandModelCatalogPublished
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
00198506089695ELMED INCORPORATEDSM-T9931FS-AN-TSM-T9931FS-AN-T2026-03-20
00198506089701ELMED INCORPORATEDSTE5502610ASTE5502610A2026-03-20
00198506089718ELMED INCORPORATEDSTE235920STE2359202026-03-20
00198506089732ELMED INCORPORATEDSTESS572004DSTESS572004D2026-03-20
00198506089749ELMED INCORPORATEDSTESS571004DSTESS571004D2026-03-20
00198506055393ELMED INCORPORATEDSTF9911FSTF9911F2026-03-19
00198506089602ELMED INCORPORATED11126-1111126-112026-03-17
00198506089619ELMED INCORPORATEDSTE3610810600STE36108106002026-03-17
00198506089626ELMED INCORPORATED23-31-040223-31-04022026-03-17
00198506089633ELMED INCORPORATED40-652540-65252026-03-17
00198506089640ELMED INCORPORATED30670-2830670-282026-03-17
00198506089657ELMED INCORPORATED42-170042-17002026-03-17
00198506089664ELMED INCORPORATED38-1093-I38-1093-I2026-03-17
00198506089671ELMED INCORPORATED69127-0369127-032026-03-17
00198506089688ELMED INCORPORATED69127-0269127-022026-03-17
00198506089510ELMED INCORPORATEDSTE11510929STE115109292026-03-13

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00190776416379MillenniumAvalign Technologies, Inc.NWW2026-02-16
10850033976356HERizon Disposable Endoscopic Scissors XLMinerva Surgical, Inc.NWW2026-02-13
00198506087943ELMED INCORPORATEDELMED INCORPORATEDNWW2026-01-16
00190776410872MillenniumAvalign Technologies, Inc.NWW2025-09-15
00190776410544MillenniumAvalign Technologies, Inc.NWW2025-09-11
06976860690412OriGynMEDOriGyn Medical Technology (Hangzhou) Co., Ltd.NWW2025-08-28
06976860690429OriGynMEDOriGyn Medical Technology (Hangzhou) Co., Ltd.NWW2025-08-28
06976860690436OriGynMEDOriGyn Medical Technology (Hangzhou) Co., Ltd.NWW2025-08-28
06976860690443OriGynMEDOriGyn Medical Technology (Hangzhou) Co., Ltd.NWW2025-08-28
06976860690450OriGynMEDOriGyn Medical Technology (Hangzhou) Co., Ltd.NWW2025-08-28
06976860690467OriGynMEDOriGyn Medical Technology (Hangzhou) Co., Ltd.NWW2025-08-28
06976860690474OriGynMEDOriGyn Medical Technology (Hangzhou) Co., Ltd.NWW2025-08-28
06976860690481OriGynMEDOriGyn Medical Technology (Hangzhou) Co., Ltd.NWW2025-08-28
06976860690498OriGynMEDOriGyn Medical Technology (Hangzhou) Co., Ltd.NWW2025-08-28
06976860690504OriGynMEDOriGyn Medical Technology (Hangzhou) Co., Ltd.NWW2025-08-28
06976860690511OriGynMEDOriGyn Medical Technology (Hangzhou) Co., Ltd.NWW2025-08-28
06976860690528OriGynMEDOriGyn Medical Technology (Hangzhou) Co., Ltd.NWW2025-08-28
06976860690535OriGynMEDOriGyn Medical Technology (Hangzhou) Co., Ltd.NWW2025-08-28
06976860690542OriGynMEDOriGyn Medical Technology (Hangzhou) Co., Ltd.NWW2025-08-28
06976860690559OriGynMEDOriGyn Medical Technology (Hangzhou) Co., Ltd.NWW2025-08-28
06976860690566OriGynMEDOriGyn Medical Technology (Hangzhou) Co., Ltd.NWW2025-08-28
06976860690573OriGynMEDOriGyn Medical Technology (Hangzhou) Co., Ltd.NWW2025-08-28
06976860690580OriGynMEDOriGyn Medical Technology (Hangzhou) Co., Ltd.NWW2025-08-28
06976860690597OriGynMEDOriGyn Medical Technology (Hangzhou) Co., Ltd.NWW2025-08-28
06976860690603OriGynMEDOriGyn Medical Technology (Hangzhou) Co., Ltd.NWW2025-08-28
06976860690610OriGynMEDOriGyn Medical Technology (Hangzhou) Co., Ltd.NWW2025-08-28
06976860690627OriGynMEDOriGyn Medical Technology (Hangzhou) Co., Ltd.NWW2025-08-28
06976860690634OriGynMEDOriGyn Medical Technology (Hangzhou) Co., Ltd.NWW2025-08-28
06976860690641OriGynMEDOriGyn Medical Technology (Hangzhou) Co., Ltd.NWW2025-08-28
06976860690658OriGynMEDOriGyn Medical Technology (Hangzhou) Co., Ltd.NWW2025-08-28