FDA.reportPublic FDA data

NA

Primary DI
04055207034705
Brand
NA
Company
Richard Wolf GmbH
Model
891603000
Catalog number
891603000
Device description
SUTURE CUTTER Ø 5MM WL 200MM take-apart, reusable
Published
2022-08-03
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
NBHAccessories, arthroscopic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NBHAccessories, ArthroscopicOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04055207034705PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04055207034705040552070347054055207034705

GMDN Terms#

Term, Definition table
TermDefinition
Flexible endoscopic scissors, reusableA hand-held flexible device used in combination with a dedicated endoscope and intended to cut tissue or sutures during an endoscopic procedure. It is typically constructed of a flexible metal coil or plastic tube whose distal end is equipped with a pair of mechanical (i.e., not electrosurgical) cutting blades operated through a control handle at the proximal end. It is introduced into the body cavity through the working channel of the endoscope. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length200Millimeter
Outer Diameter5Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

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
04055207056585HIGHFLOW223560122356012017-07-21
04055207056592HIGHFLOW223561122356112017-07-21
04055207026526ERAGON BIPOLAR83930031839300312016-09-27
04055207026533ERAGON BIPOLAR83930032839300322016-09-27
04055207026540ERAGON BIPOLAR83930033839300332016-09-27
04055207026557ERAGON BIPOLAR83930034839300342016-09-27
04055207026564ERAGON BIPOLAR83930035839300352016-09-23
04055207026588ERAGON BIPOLAR83930041839300412016-09-27
04055207026724ERAGON BIPOLAR83930921839309212016-09-27
04055207033876ERAGON BIPOLAR8393001028393001022016-09-27
04055207055540ERAGON BIPOLAR83930037839300372016-09-27
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506093258ELMED INCORPORATEDELMED INCORPORATEDNBH2026-07-28
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00810143909463SURGIPROSSurgipros, LLCNBH2026-07-28
00810143909470SURGIPROSSurgipros, LLCNBH2026-07-28
00810143909487SURGIPROSSurgipros, LLCNBH2026-07-28
00810143909494SURGIPROSSurgipros, LLCNBH2026-07-28
00810143909500SURGIPROSSurgipros, LLCNBH2026-07-28
00810143909531SURGIPROSSurgipros, LLCNBH2026-07-28
00810143909555SURGIPROSSurgipros, LLCNBH2026-07-28
00810143909562SURGIPROSSurgipros, LLCNBH2026-07-28
00810143909579SURGIPROSSurgipros, LLCNBH2026-07-28
00810143909623SURGIPROSSurgipros, LLCNBH2026-07-28
00810143909630SURGIPROSSurgipros, LLCNBH2026-07-28
00810143909647SURGIPROSSurgipros, LLCNBH2026-07-28
00810143909654SURGIPROSSurgipros, LLCNBH2026-07-28
00810143909661SURGIPROSSurgipros, LLCNBH2026-07-28
00810143909678SURGIPROSSurgipros, LLCNBH2026-07-28
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00810143909791SURGIPROSSurgipros, LLCNBH2026-07-28
00810212934334SURGIPROSSurgipros, LLCNBH2026-07-28
00810212934341SURGIPROSSurgipros, LLCNBH2026-07-28
00810212934358SURGIPROSSurgipros, LLCNBH2026-07-28
00810212934365SURGIPROSSurgipros, LLCNBH2026-07-28
00810212934372SURGIPROSSurgipros, LLCNBH2026-07-28
00810212934389SURGIPROSSurgipros, LLCNBH2026-07-28
00810212934396SURGIPROSSurgipros, LLCNBH2026-07-28
00810212934402SURGIPROSSurgipros, LLCNBH2026-07-28
00810212934419SURGIPROSSurgipros, LLCNBH2026-07-28