FDA.reportPublic FDA data

Laryngeal mirror, rhodium coated

Primary DI
04250676735164
Brand
Laryngeal mirror, rhodium coated
Company
Spiggle & Theis Medizintechnik GmbH
Model
40-525-06
Catalog number
40-525-06
Device description
with fixed hexagonal handle, size 6 22 mm
Published
2022-09-27
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
LRCINSTRUMENT, ENT MANUAL SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRCInstrument, Ent Manual SurgicalEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250676735164PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250676735164042506767351644250676735164

GMDN Terms#

Term, Definition table
TermDefinition
Laryngeal mirror, reusableA hand-held manual surgical instrument with a mirror or a surface sufficiently polished to reflect enough undiffused light to form a virtual image of an object placed before it at the distal end, intended to be used for a laryngeal examination. The mirror is affixed at an angle to a long, slender shaft with a handle at the proximal end that is held by the doctor who can manipulate the mirror close to the site of interest in the throat. 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
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
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
04251993601927Tray set with flex band and pier pin1000616-12-011000616-12-012025-12-03
04251993601934Tray set with flex band1000617-31000617-32025-12-03
04250381821503Gillies skin hook6-1240/186-1240/182025-09-29
04250676710017Hook85-900-0185-900-012025-09-29
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04250676716880ENT-single-use suction tubes, angled301302030130202025-09-29
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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