FDA.report

RZ Medizintechnik GmbH

Primary DI
04049197297790
Brand
RZ Medizintechnik GmbH
Company
RZ-Medizintechnik GmbH
Model
400-881-130
Catalog number
400-881-130
Device description
Enucleation Scissors slightly curved, blunt, 130mm, 5''
Published
2024-06-28
Public version status
New
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

Contact Domains

Product Codes

CodeName
HNFSCISSORS, OPHTHALMIC

Product Code Classifications

CodeDeviceSpecialtyClass
HNFScissors, OphthalmicOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04049197297790PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04049197297790040491972977904049197297790

GMDN Terms

TermDefinition
Enucleation scissors, reusableA hand-held, manual, ophthalmic surgical instrument intended to be used to cut tissue during surgery involving enucleation of the eye and/or its related structures (i.e., the removal of the eyeball to, e.g., remove a malignant tumour or to relieve intolerable pain in a blind eye). It comprises two pivoted blades that are usually provided with a finger and thumb ring-handle and which cut with a shearing action (i.e., the blades cut as the sharpened edges pass one another as they are closed). It is typically made of high-grade stainless steel and is available in various designs and sizes; some designs may additionally be used for cutting sutures and drapes. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+49746294700info@rz-medizintechnik.com

Regulatory Flags

DUNS number
312953227
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
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

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04049197178747RZ Medizintechnik GmbH253-000-368253-000-3682025-07-30
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