FDA.reportPublic FDA data

Fisch footplate perforator

Primary DI
04250381849538
Brand
Fisch footplate perforator
Company
Spiggle & Theis Medizintechnik GmbH
Model
10-658-08
Catalog number
10-658-08
Device description
0.8 mm, 16 cm
Published
2022-09-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JYSPERFORATOR, EAR-LOBE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JYSPerforator, Ear-LobeEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250381849538PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250381849538042503818495384250381849538

GMDN Terms#

Term, Definition table
TermDefinition
Automatic cranial perforator, reusableA metallic rotary endpiece designed to cut a hole(s) or a circular section(s) of the skull vault (calvarium) to provide access to the interior for diagnostic/therapeutic purposes or for the removal of a bone flap for brain surgery. It is available in various configurations such as: 1) two coaxial drill shafts (one rotating inside the other with the inner drill shaft extending slightly beyond the outer cutter); or 2) a single trepan bur rotating a in protective sleeve, both having a drive shank that connects to a powered handpiece and a built-in clutch mechanism that disengages with penetration of the cutter through the skull. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+492206908165c.winterschladen@spiggle-theis.com

Regulatory Flags#

DUNS number
332893028
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true
Sterilization required before use
true

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04250676736055Fiberglass light carrier50-234-0350-234-032025-09-15
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04250381858400Fiberglass lightcarrier for rigid and50-205-7050-205-702022-09-27
04250381858509Fiberglass lightcarrier for laser50-217-1250-217-122022-09-27
04250381858516Fibreglass light carrier for laser50-217-3650-217-362022-09-27
04250381858523Fiberglass lightcarrier for laser50-217-7050-217-702022-09-27
04250676736048Fiberglass light carrier50-234-0250-234-022022-09-27
04250676701800Fibre light carrier20-155-0020-155-002022-09-14
04250676748188Endoragard teeth protector50-240-0050-240-002026-04-27
04250676748195Medasil teeth protector50-250-0050-250-002022-09-27
04050659354647Brünings anastignatic aural magnifier10-180-0010-180-002026-01-21
04250676747204Tray set with flex band and pier pin1000616-12-011000616-12-012025-12-03
04250676747211Tray set with flex band1000617-31000617-32025-12-03
04250676747235Filter modul with 8 x LM10-845-0110-845-012025-12-03
04250676747228Tray set1000617-3-01000617-3-02025-12-03
04251993600128Filter modul with 8 x LM10-845-0110-845-012025-12-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860013956509Richline Group, Inc. d/b/a InvernessRichline Group, Inc.JYS2026-02-26
00860013956516Richline Group, Inc. d/b/a InvernessRichline Group, Inc.JYS2026-02-26
00860013956523Richline Greoup, Inc. d/b/a InvernessRichline Group, Inc.JYS2026-02-26
00860013956561Richline Group, Inc. d/b/a InvernessRichline Group, Inc.JYS2026-02-26
00860013956578Richline Group, Inc. d/b/a InvernessRichline Group, Inc.JYS2026-02-26
00860013956585Richline Group, Inc. d/b/a InvernessRichline Group, Inc.JYS2026-02-26
00860013956592Richline Group, Inc. d/b/a InvernessRichline Group, Inc.JYS2026-02-26
00860014537103Richline Group, Inc. d/b/a InvernessRichline Group, Inc.JYS2026-02-26
00757770409228Bausch + LombBausch & Lomb IncorporatedJYS2025-08-15
04250676735539Fisch footplate perforatorSpiggle & Theis Medizintechnik GmbHJYS2023-08-30
04250381848449Fisch footplate perforatorSpiggle & Theis Medizintechnik GmbHJYS2022-09-13
04250381849491Fisch footplate perforatorSpiggle & Theis Medizintechnik GmbHJYS2022-09-13
04250381849507Fisch footplate perforatorSpiggle & Theis Medizintechnik GmbHJYS2022-09-13
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04250381849927Politzer tympanum perforatorSpiggle & Theis Medizintechnik GmbHJYS2022-09-09
04250381849934Lucae tympanum perforatorSpiggle & Theis Medizintechnik GmbHJYS2022-09-09