ENDO-SPIKE 491403000

GUDID 04055207050279

NEEDLES FOR STITCHING FORCEPS for ENDO-SPIKE 891403000, PACK = 5 PCS, sterile, for single use

Richard Wolf GmbH

General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use
Primary Device ID04055207050279
NIH Device Record Keyd2ce969b-d376-4902-aed3-b14edaa199ae
Commercial Distribution Discontinuation2023-09-14
Commercial Distribution StatusNot in Commercial Distribution
Brand NameENDO-SPIKE
Version Model Number491403000
Catalog Number491403000
Company DUNS315304071
Company NameRichard Wolf GmbH
Device Count5
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+497043350
Emailinfo@richard-wolf.com
Phone+497043350
Emailinfo@richard-wolf.com
Phone+497043350
Emailinfo@richard-wolf.com
Phone+497043350
Emailinfo@richard-wolf.com
Phone+497043350
Emailinfo@richard-wolf.com
Phone+497043350
Emailinfo@richard-wolf.com
Phone+497043350
Emailinfo@richard-wolf.com
Phone+497043350
Emailinfo@richard-wolf.com
Phone+497043350
Emailinfo@richard-wolf.com
Phone+497043350
Emailinfo@richard-wolf.com
Phone+497043350
Emailinfo@richard-wolf.com
Phone+497043350
Emailinfo@richard-wolf.com
Phone+497043350
Emailinfo@richard-wolf.com
Phone+497043350
Emailinfo@richard-wolf.com
Phone+497043350
Emailinfo@richard-wolf.com
Phone+497043350
Emailinfo@richard-wolf.com
Phone+497043350
Emailinfo@richard-wolf.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS104055207049150 [Primary]
GS104055207050279 [Unit of Use]

FDA Product Code

NBHAccessories, arthroscopic

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[04055207050279]

Moist Heat or Steam Sterilization


[04055207050279]

Moist Heat or Steam Sterilization


[04055207050279]

Moist Heat or Steam Sterilization


[04055207050279]

Moist Heat or Steam Sterilization


[04055207050279]

Moist Heat or Steam Sterilization


[04055207050279]

Moist Heat or Steam Sterilization


[04055207050279]

Moist Heat or Steam Sterilization


[04055207050279]

Moist Heat or Steam Sterilization


[04055207050279]

Moist Heat or Steam Sterilization


[04055207050279]

Moist Heat or Steam Sterilization


[04055207050279]

Moist Heat or Steam Sterilization


[04055207050279]

Moist Heat or Steam Sterilization


[04055207050279]

Moist Heat or Steam Sterilization


[04055207050279]

Moist Heat or Steam Sterilization


[04055207050279]

Moist Heat or Steam Sterilization


[04055207050279]

Moist Heat or Steam Sterilization


[04055207050279]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2023-09-22
Device Publish Date2022-11-01

Devices Manufactured by Richard Wolf GmbH

04055207069776 - NA2024-04-09 SEAL Ø 11MM silicone seal, blue, for instruments 3-6mm, Length 2mm, reusable
04055207069783 - NA2024-04-09 SEALING MEMBRANE Ø 17MM yellow, Ø 17mm, PACK=10 PCS, for instruments from 3 to 6mm
04055207056691 - NA2024-04-08 LASER WORKING ELEMENT PASSIVE 12/30° closed, with locking mechanism for laser fibers, compatible with telescopes Ø 4mm, bayon
04055207056707 - NA2024-04-08 LASER WORKING INSERT 12/30° compatible with telescopes Ø 4mm, with locking mechanism for laser fiber, bayonet-lock, reusable
04055207057247 - NA2024-04-08 GUIDE SHEATH LASER THERAPY 1000µM 22FR with lateral guide, distal end straight, reusable
04055207057254 - NA2024-04-08 GUIDE SHEATH LASER THERAPY 1000µM 24FR with lateral guide, distal end straight, reusable
04055207057261 - NA2024-04-08 GUIDE SHEATH LASER THERAPY 600µM 22FR with lateral guide, distal end straight, reusable
04055207057278 - NA2024-04-08 GUIDE SHEATH LASER THERAPY 600µM 24FR with lateral guide, distal end straight, reusable

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