FDA.report

ARTHROLINE

Primary DI
04055207046319
Brand
ARTHROLINE
Company
Richard Wolf GmbH
Model
891400302
Catalog number
89140.0302
Device description
BASKET PUNCH W 6.5MM H 2.1MM jaw section oval and curved upward, movable jaw section serrated, sheath straight, WL 120mm, reusable
Published
2022-08-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
NBHAccessories, arthroscopic

Product Code Classifications

CodeDeviceSpecialtyClass
NBHAccessories, ArthroscopicOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04055207046319PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04055207046319040552070463194055207046319

GMDN Terms

TermDefinition
Rigid endoscopic scissors, reusableA hand-held rigid device used in combination with a dedicated endoscope and intended to cut tissue or sutures during an endoscopic procedure. It is typically constructed of stainless steel and is designed as a long pair of parallel sliding arms whose distal end is equipped with a pair of mechanical (i.e., not electrosurgical) cutting blades operated through a ringed handle at the proximal end. It is typically introduced into the body cavity through the working channel of the endoscope. This is a reusable device.

Device Sizes

TypeValueUnit
Height2.1Millimeter
Width6.5Millimeter

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+497043350info@richard-wolf.com

Regulatory Flags

DUNS number
315304071
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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04055207067994VERTEBRIS8922020078922020072025-11-17
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