FDA.report

devemed

Primary DI
04061644017201
Brand
devemed
Company
devemed GmbH
Model
2406-42
Device description
Caliper "Castroviejo" | 9 cm curved / 0-40 mm
Published
2020-04-17
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
EILGauge, Depth, Instrument, Dental

Product Code Classifications

CodeDeviceSpecialtyClass
EILGauge, Depth, Instrument, DentalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04061644017201PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04061644017201040616440172014061644017201

GMDN Terms

TermDefinition
FacebowA caliper-like dental device intended for use in denture fabrication to record the relative position of the maxillary arch to the temporomandibular joint (TMJ), or the spatial relationship between the upper and lower jaws. This determination is intended for use in placing denture casts accurately into an articulator and thereby aiding correct placement of artificial teeth into a denture base. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+4974679491990info@devemed.de

Regulatory Flags

DUNS number
506826739
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
false
Sterilization required before use
true

Other Devices From This Company

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04061644065349Reicodent02-1086-41 C2020-12-29
04061644065356Reicodent02-1086-10 C2020-12-29
04061644065363Reicodent02-1086-11 C2020-12-29
04061644065370Reicodent02-1086-30 C2020-12-29
04061644065387Reicodent02-1086-31 C2020-12-29
04061644065394Reicodent02-1086-60 C2020-12-29
04061644065400Reicodent02-1086-61 C2020-12-29
04061644004058devemed720-1002020-04-21
04061644004072devemed725-32020-04-21
04061644004089devemed725-42020-04-21
04061644004355devemed790-12020-04-21
04061644004362devemed790-22020-04-21
04061644004379devemed790-32020-04-21
04061644004454devemed794-602020-04-21
04061644004461devemed794-612020-04-21
04061644004478devemed794-622020-04-21
04061644007646devemed794-3412020-04-21
04061644008667devemed793-AS-12020-04-21

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