FDA.report

BMT Medizintechnik GmbH

Primary DI
04251725204792
Brand
BMT Medizintechnik GmbH
Company
BMT Medizintechnik GmbH
Model
BT-287
Catalog number
BT-287
Device description
RETRACTOR ROUX-MAGNUS, DOUBLE, 15 CM
Published
2020-05-05
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
EIGRETRACTOR, ALL TYPES

Product Code Classifications

CodeDeviceSpecialtyClass
EIGRetractor, All TypesDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04251725204792PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04251725204792042517252047924251725204792

GMDN Terms

TermDefinition
Hand-held dental retractorA hand-held, non-self-retaining dental instrument intended to be used to manually displace soft tissues of the oral cavity to improve their visualization and access, and to afford them protection during oral surgical procedures. It is typically a metallic device and includes a shaped/hooked blade with a handle/holding portion. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+497461966750pmarcis@bmtsurgical.com

Regulatory Flags

DUNS number
342582423
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
true
Sterilization required before use
true

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