FDA.reportPublic FDA data

Premier

Primary DI
D6919030610
Brand
Premier
Company
PREMIER DENTAL PRODUCTS COMPANY
Model
9030610
Device description
TENACULUM CERV ATRAU JAW 1/4 IN
Published
2016-09-19
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
HDCTenaculum, Uterine

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HDCTenaculum, UterineObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D6919030610PrimaryHIBCC0

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

Regulatory Flags#

DUNS number
014789663
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
00348783011234Premier Jarcho Cannula10308402026-06-10
00348783011340Premier Needle Adapter10324532026-06-10
00348783011357Premier Needle Adapter10324542026-06-10
00348783011364Premier Needle Adapter10324552026-06-10
00348783011371Premier Needle Adapter10324562026-06-10
00348783011456Premier Sawyer Retractor10501052026-06-10
00348783011463Premier Sawyer Retractor10501062026-06-10
00348783012415Premier Jackson Improved Short Tracheostomy Tube81000412026-06-10
00348783015591Bond-PR30052502026-06-10
00348783015607Bond-PR30052552026-06-10
00348783015614Bond-PR30052692026-06-10
00348783010640Premier Jackson Original Tracheostomy Tube10343002026-06-09
00348783010657Premier Jackson Original Tracheostomy Tube10343102026-06-09
00348783010664Premier Jackson Original Tracheostomy Tube10343112026-06-09
00348783010671Premier Jackson Original Tracheostomy Tube10343122026-06-09
00348783010695Premier Jackson Original Tracheostomy Tube10343142026-06-09
00348783010701Premier Jackson Original Tracheostomy Tube10343152026-06-09
00348783010718Premier Jackson Original Tracheostomy Tube10343162026-06-09
00348783010725Premier Jackson Original Tracheostomy Tube10343172026-06-09
00348783010732Premier Jackson Original Tracheostomy Tube10343182026-06-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850071684162Realstar SurgicalREAL STAR SURGICAL INSTRUMENTSHDC2025-01-21
00850071684179Realstar SurgicalREAL STAR SURGICAL INSTRUMENTSHDC2025-01-21
00850071684186Realstar SurgicalREAL STAR SURGICAL INSTRUMENTSHDC2025-01-21
00850071684193Realstar SurgicalREAL STAR SURGICAL INSTRUMENTSHDC2025-01-21
00850071684209Realstar SurgicalREAL STAR SURGICAL INSTRUMENTSHDC2025-01-21
00850071684216Realstar SurgicalREAL STAR SURGICAL INSTRUMENTSHDC2025-01-21
00850071684223Realstar SurgicalREAL STAR SURGICAL INSTRUMENTSHDC2025-01-21
00860012999606Realstar SurgicalREAL STAR SURGICAL INSTRUMENTSHDC2025-01-21
04046955057191AESCULAPAESCULAP, INC.HDC2020-10-19
00304040015971Henry ScheinHENRY SCHEIN, INC.HDC2018-10-17
GYNXLT22500LLETZ Braun TenaculumGYNEX CORPORATIONHDC2017-01-19
10381780177616Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDC2016-12-29
10381780176800Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDC2016-12-29
10612479141961McKessonMCKESSON MEDICAL-SURGICAL INC.HDC2016-12-09
10612479143606McKessonMCKESSON MEDICAL-SURGICAL INC.HDC2016-12-09
GYNX32100Iris HookGYNEX CORPORATIONHDC2016-10-10
GYNX32200Emmett TenaculumGYNEX CORPORATIONHDC2016-10-10
GYNX32250Angle HookGYNEX CORPORATIONHDC2016-10-10
GYNX322702-Prong HookGYNEX CORPORATIONHDC2016-10-10
GYNX322903-Prong HookGYNEX CORPORATIONHDC2016-10-10
GYNX32300LLETZ Iris HookGYNEX CORPORATIONHDC2016-10-10
GYNX32400LLETZ Emmett TenaculumGYNEX CORPORATIONHDC2016-10-10
GYNX32450LLETZ Angle HookGYNEX CORPORATIONHDC2016-10-10
GYNX32490LLETZ Braun Standard TenaculumGYNEX CORPORATIONHDC2016-10-10
GYNX35000Schroeder TenaculumGYNEX CORPORATIONHDC2016-10-10
GYNX35010Schroeder Tenaculum, Double ToothGYNEX CORPORATIONHDC2016-10-10
GYNX35020Braun TenaculumGYNEX CORPORATIONHDC2016-10-10
GYNX35300Schroeder Tenaculum, AngledGYNEX CORPORATIONHDC2016-10-10
GYNX35320Braun Tenaculum, AngledGYNEX CORPORATIONHDC2016-10-10
GYNX35340Skeane Tenaculum, Slight CurveGYNEX CORPORATIONHDC2016-10-10