FDA.reportPublic FDA data

AESCULAP

Primary DI
04046955057191
Brand
AESCULAP
Company
AESCULAP, INC.
Model
MG450R
Catalog number
MG450R
Device description
HULKA TENACULUM FCPS 1 PRG & PROBE 280MM
Published
2020-10-19
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
HDCTenaculum, uterine

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04046955057191PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046955057191040469550571914046955057191

GMDN Terms#

Term, Definition table
TermDefinition
Surgical soft-tissue manipulation forceps, scissors-like, reusableA hand-held, manual, open-surgery instrument designed to grasp, manipulate, dissect, and/or clamp soft-tissues (e.g., organs, blood vessels); it is not intended for grasping/clamping bone or teeth, nor is it dedicated to ophthalmic surgery and is not a dedicated biopsy device. It has a scissors-like hinged design with ring handles and blades (non-cutting) that may be available in a range of sizes or designs. It may be intended for use at a specific anatomy. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)282-9000GUDID.BBMUS_Service@bbraun.com

Regulatory Flags#

DUNS number
082594540
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04046964676628AESCULAPUS399US3992016-09-22
04046964256967AESCULAPUS910US9102016-09-22
05055049000608AESCULAPUS905US9052016-09-22
05055049007423AESCULAPUS906US9062016-09-22
04046955074624AESCULAPFF025RFF025R2019-04-30
04046955074631AESCULAPFF026RFF026R2019-04-30
04046955074648AESCULAPFF027RFF027R2019-04-30
04046955074655AESCULAPFF028RFF028R2019-04-30
04046955074662AESCULAPFF029RFF029R2019-04-30
04046955074716AESCULAPFF086RFF086R2019-04-30
04046955074723AESCULAPFF087RFF087R2019-04-30
04046955074730AESCULAPFF088RFF088R2019-04-30
04046955074792AESCULAPFF136RFF136R2019-04-30
04046955074808AESCULAPFF137RFF137R2019-04-30
04046955074815AESCULAPFF138RFF138R2019-04-30
04046955074822AESCULAPFF690RFF690R2019-04-30
04046955074914AESCULAPFF828RFF828R2019-04-30
04046955074921AESCULAPFF829RFF829R2019-04-30
04046955074938AESCULAPFF830RFF830R2019-04-30
04046955074945AESCULAPFF831RFF831R2019-04-30

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
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
GYNX35360Teale Tenaculum, Slight CurveGYNEX CORPORATIONHDC2016-10-10