FDA.report

HAND CONTROL, ALLEGRO, REFURB

Primary DI
00842430103483
Brand
HAND CONTROL, ALLEGRO, REFURB
Company
MIZUHO ORTHOPEDIC SYSTEMS, INC.
Model
6807-3R
Catalog number
6807-3R
Published
2018-10-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
KXJTable, Radiologic

Product Code Classifications

CodeDeviceSpecialtyClass
KXJTable, RadiologicRadiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00842430103483PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00842430103483008424301034838424301034830842430103483

GMDN Terms

TermDefinition
Operating room equipment remote controlA hand-operated electronic unit with a configuration of analogue or digital push-buttons (alphanumeric, colour-, or symbol-coded) designed to control the functions of an operating table (e.g., orthopaedic operating table, ophthalmic operating table), lights, and/or cameras in the operating room (OR) from a distance via a connected cable or wirelessly [e.g., radio-frequency (RF), infrared (IR) transmission]. It is intended to be operated by the healthcare provider.

Sterilization Methods

Method

Contacts

PhoneEmail
1-800-777-4674CustServ@mizuhosi.com

Regulatory Flags

DUNS number
084527241
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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00842430109171ADANTE DAA HIP PROCEDURE KIT, RIGHT6895AH-R6895AH-R2025-07-28
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