FDA.reportPublic FDA data

Fisch reference instrument

Primary DI
04250381848401
Brand
Fisch reference instrument
Company
Spiggle & Theis Medizintechnik GmbH
Model
10-653-02
Catalog number
10-653-02
Device description
for stapes prostheses, curved 3.5 / 4.0 / 4.5 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
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
JYJGAUGE, MEASURING

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JYJGauge, MeasuringEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250381848401PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250381848401042503818484014250381848401

GMDN Terms#

Term, Definition table
TermDefinition
Surgical depth gauge, reusableA surgical instrument designed to measure the depth of a recess, usually to measure the depth of holes being drilled in bone so that the surgeon can determine the length of the bone screw to be used. It may take two forms: 1) a device with a moveable (sliding) centrepiece (a prong), the tip of which is inserted into the recess to read from a scale; 2) a circular disc with a central hole which is clipped to a drill bit so that the device slides up as the drill bit is advanced. This is a reusable device intended to be sterilized prior to use.

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
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
true

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04250676747204Tray set with flex band and pier pin1000616-12-011000616-12-012025-12-03
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04251993600128Filter modul with 8 x LM10-845-0110-845-012025-12-03
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04250676716897ENT-single-use suction tubes, angled301303030130302025-09-29
04250676731982Salivary duct probe40-611-0040-611-002025-09-29
04250676731999Salivary duct probe40-611-0140-611-012025-09-29
04250676732002Salivary duct probe40-611-0240-611-022025-09-29
04250676732026Salivary duct probe40-611-0440-611-042025-09-29
04250676732033Salivary duct probe40-611-0540-611-052025-09-29
04250676740625Bowman salivary duct probe40-609-4040-609-402025-09-29
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00840183527501BR Surgical, LLCBR Surgical, LLCJYJ2024-11-26
00887482114223Symmetry Surgical®SYMMETRY SURGICAL INC.JYJ2024-08-20
00887482113387Symmetry Surgical®SYMMETRY SURGICAL INC.JYJ2024-08-12
00190776378448MillenniumAvalign Technologies, Inc.JYJ2023-11-13
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00190776289232MillenniumAVALIGN TECHNOLOGIES, INC.JYJ2023-06-23
00842331168475Novo Surgical Inc. NOVO SURGICAL, INC.JYJ2022-11-13
00842331131288Novo Surgical Inc. NOVO SURGICAL, INC.JYJ2022-11-10
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