FDA.report

MaxMoreSpine

Primary DI
04260200310583
Brand
MaxMoreSpine
Company
Hoogland Spine Products GmbH
Model
1001-EK 002
Device description
Endo Kerrison Ø 3,5 mm/ 330 mm/40°
Published
2022-02-28
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

Product Codes

CodeName
LRYPunch, Surgical

Product Code Classifications

CodeDeviceSpecialtyClass
LRYPunch, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04260200310583PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04260200310583042602003105834260200310583

GMDN Terms

TermDefinition
Rigid endoscopic biopsy forceps, reusableA rigid, manual, non-electrosurgical instrument intended to obtain tissue specimens during endoscopic procedures (e.g., laparoscopy, thoracoscopy, spinoscopy, arthroscopy). It is typically constructed as a long instrument with one sliding and one stationary rod whose distal ends are equipped with scissors-like cups with cutting edge rims, which are operated by a control handle at the proximal end of the instrument. It is introduced into the body through an artificial orifice of the body or the working channel of the endoscope. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
507292204
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

Other Devices From This Company

Primary DIBrandModelCatalogPublished
04260200314079MaxMoreSpine1002-TS 0072022-08-31
04260200314086MaxMoreSpine1002-TS 0082022-08-31
04260200314093MaxMoreSpine1002-TS 0092022-08-31
04260200314109MaxMoreSpine1002-TS 0102022-08-31
04260200312525MaxMoreSpine1001-BE 001/H2022-08-02
04260200312532MaxMoreSpine1001-BE 001/S2022-08-02
04260200313096MaxMoreSpine1001-BE-0032022-08-02
04260200313102MaxMoreSpine1001-BE-0022022-08-02
04260200313119MaxMoreSpine1001-BE-0042022-08-02
04260200313690MaxMoreSpine1001-BE 004/S 2022-08-02
04260200313560MaxMoreSpine1001-IS 0122022-03-15
04260200313867MaxMoreSpine1001-IS 0142022-03-15
04260200313874MaxMoreSpine1001-DF 001-D2022-03-15
04260200313881MaxMoreSpine1001-DC 0182022-03-15
04260200313898MaxMoreSpine1001-EF 001/1M-D2022-03-15
04260200313904MaxMoreSpine1001-EF 003/1U2022-03-15
04260200313911MaxMoreSpine1001-EF 005/1B-D2022-03-15
04260200313928MaxMoreSpine1001-EF 0092022-03-15
04260200313935MaxMoreSpine1001-EF 009B-D2022-03-15
04260200313942MaxMoreSpine1001-EF 035B-D2022-03-15

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