FDA.report

Scalpel blades

Primary DI
04048614010127
Brand
Scalpel blades
Company
Spiggle & Theis Medizintechnik GmbH
Model
10-360-10
Catalog number
10-360-10
Device description
no. 10, single sterile packed 100 pieces
Published
2022-09-09
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
GESBLADE, SCALPEL

Product Code Classifications

CodeDeviceSpecialtyClass
GESBlade, ScalpelGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04048614010127PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04048614010127040486140101274048614010127

GMDN Terms

TermDefinition
Manual scalpel blade, reusableAn interchangeable device designed to mount a compatible handle and function as the cutting edge of a scalpel. The device is made of high-grade stainless steel alloy and is used as a surgical instrument to cut and dissect tissues. This is a reusable device.

Sterilization Methods

Method

Contacts

PhoneEmail
+492206908165c.winterschladen@spiggle-theis.com

Regulatory Flags

DUNS number
332893028
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
true
Sterilization required before use
false

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Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
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