FDA.report

n.a.

Primary DI
04048551161333
Brand
n.a.
Company
Karl Storz GmbH & Co. KG
Model
41201LN
Device description
Shaver Blade, diameter 4 mm
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
ERLDRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE

Product Code Classifications

CodeDeviceSpecialtyClass
ERLDrill, Surgical, Ent (Electric Or Pneumatic) Including HandpieceEar, Nose, Throat2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04048551161333PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04048551161333040485511613334048551161333

GMDN Terms

TermDefinition
Tissue morcellation systemAn assembly of devices used to mechanically cut (slice), core (cut a hole into), peel (remove surface), and extract selected tissue from the body (a process known as morcellation), typically during laparoscopic surgery (e.g., for tumour or fibroid removal). It typically consists of a handpiece (high-speed rotating blade and holder) for tissue resection and extraction, a mains electricity (AC-powered) control unit that drives the handpiece blade, a remote drive cable to connect the handpiece with the control unit, and a foot-switch; some designs may also provide suction intended for removal of resected tissue.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
315731430
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
04048551232378n.a.27033U27033U2025-08-11
04048551232781n.a.27047B27047B2025-08-11
04048551418123n.a.TC304USTC304US2025-08-11
04048551210567n.a.8574GY8574GY2018-09-04
04048551210574n.a.8574GZ8574GZ2018-09-04
04048551211281n.a.8587K8587K2018-09-04
04048551211427n.a.8588K8588K2018-09-04
04048551211694n.a.8590KC8590KC2018-09-04
04048551425749n.a.40410LH40410LH2025-07-10
04048551425756n.a.40410LS40410LS2025-07-10
04048551425763n.a.40410LG40410LG2025-07-10
04048551425770n.a.40410LC40410LC2025-07-10
04048551425787n.a.40410LL40410LL2025-07-10
04048551425794n.a.40410LF40410LF2025-07-10
04048551425800n.a.40410LR40410LR2025-07-10
04048438008867NA051111-10051111-102025-03-28
04048438008911NA051110-10051110-102025-03-28
04048551010242NA497HCS497HCS2025-03-28
04048551012468NA11900RA11900RA2025-03-28
04048551061343NA20090331200903312025-03-28

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00199150001989MR8MEDTRONIC POWERED SURGICAL SOLUTIONSERL2026-03-09
00763000892951M4MEDTRONIC XOMED, INC.ERL2026-02-28
J021305030001Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHERL2025-09-22
J021305030011Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHERL2025-09-22
J021305030021Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHERL2025-09-22
J021305030031Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHERL2025-09-22
J021305030041Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHERL2025-09-22
J021305030051Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHERL2025-09-22
J021305030061Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHERL2025-09-22
J021305030071Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHERL2025-09-22
J021305030081Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHERL2025-09-22
J021305030091Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHERL2025-09-22
J021305030101Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHERL2025-09-22
J021305030111Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHERL2025-09-22
J021305030121Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHERL2025-09-22
J021305030131Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHERL2025-09-22
J021305030141Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHERL2025-09-22
J021305030151Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHERL2025-09-22
J021305030161Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHERL2025-09-22
J021305030171Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHERL2025-09-22
J021305030181Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHERL2025-09-22
J021305030191Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHERL2025-09-22
J021305030201Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHERL2025-09-22
J021305030211Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHERL2025-09-22
J021305030221Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHERL2025-09-22
J021305030231Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHERL2025-09-22
J021305030241Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHERL2025-09-22
00763000722401MIDAS REX MR8MEDTRONIC POWERED SURGICAL SOLUTIONSERL2025-07-21
J021305000000Piezomed Pro M-PM100W & H Dentalwerk Bürmoos GmbHERL2025-07-08
J021305010000Piezomed Pro M-PH350W & H Dentalwerk Bürmoos GmbHERL2025-07-08