FDA.reportPublic FDA data

LEEP Emmett Tenaculum

Primary DI
00888937016321
Brand
LEEP Emmett Tenaculum
Company
Coopersurgical, Inc.
Model
F805
Device description
LEEP Emmett Tenaculum - Coated 250 mm
Published
2022-11-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HFBForceps, Biopsy, Gynecological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HFBForceps, Biopsy, GynecologicalObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888937016321PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888937016321008889370163218889370163210888937016321

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length250Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
801895244
Device count
1
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888937028508LifeGlobal® MediaH5TF-010MH5TF-010M2026-05-11
00888937028515LifeGlobal® MediaH5TF-050MH5TF-050M2026-05-11
00888937028522LifeGlobal® MediaH5TF-100MH5TF-100M2026-05-11
00888937028539LifeGlobal® MediaLGGF-050MLGGF-050M2026-05-11
00888937028546LifeGlobal® MediaLGGF-100MLGGF-100M2026-05-11
00888937028614LifeGlobal® MediaGCOL-100MGCOL-100M2026-05-11
00888937028621LifeGlobal® MediaGCOL-500MGCOL-500M2026-05-11
00888937028638LifeGlobal® MediaLGOL-100MLGOL-100M2026-05-11
00888937028645LifeGlobal® MediaLGOL-500MLGOL-500M2026-05-11
00888937028652LifeGlobal® MediaAMLO-100MAMLO-100M2026-05-11
00888937028669LifeGlobal® MediaLGPO-100MLGPO-100M2026-05-11
00888937028676LifeGlobal® MediaLGPO-500MLGPO-500M2026-05-11
00888937028683LifeGlobal® MediaAMPO-100MAMPO-100M2026-05-11
00888937028690LifeGlobal® MediaLGUA-100MLGUA-100M2026-05-11
00888937028706LifeGlobal® MediaLGUA-500MLGUA-500M2026-05-11
00888937028713LifeGlobal® MediaAMLG-100MAMLG-100M2026-05-11
00888937028935LifeGlobal® MediaH5TH-050MH5TH-050M2026-05-11
00888937028942LifeGlobal® MediaH5TH-100MH5TH-100M2026-05-11
00888937029017LifeGlobal® MediaLGGH-050MLGGH-050M2026-05-11
00888937029024LifeGlobal® MediaLGGH-100MLGGH-100M2026-05-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06950190431006NAZhuji Pengtian Medical Instrument Co.,Ltd.HFB2026-03-31
00190776418014MillenniumAvalign Technologies, Inc.HFB2026-03-23
00850033976366HERizon Disposable Endoscopic Forceps – Alligator XLMinerva Surgical, Inc.HFB2026-02-12
00840306837302Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.HFB2025-10-24
00840306837319Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.HFB2025-10-24
04059453057327Hermann Medizintechnik GmbHHermann Medizintechnik GmbHHFB2025-08-28
06973672291066JiyuanJiangsu Jiyuan Medical Technology Co .,Ltd.HFB2025-08-12
16973672291063JiyuanJiangsu Jiyuan Medical Technology Co .,Ltd.HFB2025-08-12
00194613029302MSI Precision Specialty InstrumentsMed Saver, Inc.HFB2025-08-01
00194613033590MSI Precision Specialty InstrumentsMed Saver, Inc.HFB2025-08-01
00194613060480MSI Precision Specialty InstrumentsMed Saver, Inc.HFB2025-08-01
00194613106423MSI Precision Specialty InstrumentsMed Saver, Inc.HFB2025-08-01
00194613108076MSI Precision Specialty InstrumentsMed Saver, Inc.HFB2025-08-01
00194613117641MSI Precision Specialty InstrumentsMed Saver, Inc.HFB2025-08-01
00194613117726MSI Precision Specialty InstrumentsMed Saver, Inc.HFB2025-08-01
06973672291059JiyuanJiangsu Jiyuan Medical Technology Co .,Ltd.HFB2025-07-31
16973672291056JiyuanJiangsu Jiyuan Medical Technology Co .,Ltd.HFB2025-07-31
00190776406974MillenniumAvalign Technologies, Inc.HFB2025-07-25
05010058082595InstrapacROBINSON HEALTHCARE LIMITEDHFB2025-06-25
05010058182592InstrapacROBINSON HEALTHCARE LIMITEDHFB2025-06-25
05010058080478InstrapacROBINSON HEALTHCARE LIMITEDHFB2025-06-23
05010058180475InstrapacROBINSON HEALTHCARE LIMITEDHFB2025-06-23
00190776401771MillenniumAvalign Technologies, Inc.HFB2025-06-13
00198506083013ELMED INCORPORATEDELMED INCORPORATEDHFB2025-05-22
05010058082588InstrapacROBINSON HEALTHCARE LIMITEDHFB2025-05-21
05010058182585InstrapacROBINSON HEALTHCARE LIMITEDHFB2025-05-21
00840183530112BR Surgical, LLCBR Surgical, LLCHFB2025-05-14
04049047044215GimmiGimmi GmbHHFB2025-05-14
04049047044246GimmiGimmi GmbHHFB2025-05-14
04049047044291GimmiGimmi GmbHHFB2025-05-14