FDA.reportPublic FDA data

NA

Primary DI
04055207039977
Brand
NA
Company
Richard Wolf GmbH
Model
837025
Catalog number
8370.25
Device description
UTERUS GRASPING FORCEPS WL 92MM by Pozzi, with distally overlapping tip, TL 254mm, reusable
Published
2016-09-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
04055207039977PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04055207039977040552070399774055207039977

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. 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length92Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization
Moist Heat or Steam Sterilization;Ethylene Oxide;Hydrogen Peroxide

Contacts#

Phone, Email table
PhoneEmail
+497043350info@richard-wolf.com

Regulatory Flags#

DUNS number
315304071
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
04055207066805NA880888.082026-06-02
04055207007709NA180118.012026-05-29
04055207007723RIWO880388.032026-05-29
04055207007747NA890089.002026-05-29
04055207007792NA890589.052026-05-29
04055207007815NA890989.092026-05-29
04055207007839NA892089.202026-05-29
04055207008409NA8917189.1712026-05-29
04055207038505RIWO880088.002026-05-29
04055207038529RIWO880288.022026-05-29
04055207038536RIWO880488.042026-05-29
04055207011478NA8863758863.752026-05-19
04055207011539NA8913608913.602026-05-19
04055207054390NA417022284170.22282026-05-19
04055207048788NA484076448407642026-05-13
04055207008881NA8061168061.162016-09-23
04055207008898NA8061258061.252016-09-23
04055207008904NA8061358061.352016-09-23
04055207008911NA8062358062.352016-09-23
04055207012611NA40702534070.2532016-09-23

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Primary DI, Brand, Company table
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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