FDA.report

Bone Management

Primary DI
E0HM79ALV181
Brand
Bone Management
Company
Hager & Meisinger Gesellschaft mit beschränkter Haftung
Model
ALV18
Catalog number
ALV18
Device description
Surgical Contouring and Modification Kit (rotary instruments)
Published
2021-09-15
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
GFFBUR, SURGICAL, GENERAL & PLASTIC SURGERY

Product Code Classifications

CodeDeviceSpecialtyClass
GFFBur, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
E0HM79ALV181PrimaryHIBCC0

GMDN Terms

TermDefinition
Dental/maxillofacial surgical procedure kit, non-medicated, reusableA collection of various dental/surgical instruments, dressings and the necessary materials intended to be used to perform a dental or oral/maxillofacial surgical procedure. It does not contain any pharmaceuticals. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1 (303) 268-5400info@meisingerusa.com

Regulatory Flags

DUNS number
318034329
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
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
false
Sterilization required before use
true

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E0HM266736454BE00101n/a6736-4546736-4542026-02-04
E0HM266736463BE00101n/a6736-4636736-4632026-02-04
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E0HMSAGE011n/aSAGE01SAGE012026-02-04
E0HM266735268BE00101n/a6735-2686735-2682025-07-11
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E0HM266736285BE00101n/a6736-2856736-2852025-07-11
E0HM266736338BE00101n/a6736-3386736-3382025-07-11
E0HM266736383BE00101n/a6736-3836736-3832025-07-11
E0HM39310540000001Bone Management31054310542025-07-11
E0HM39MSTDW1Bone ManagementMSTDWMSTDW2025-07-11
E0HM740SSA011n/aSSA01SSA012025-07-11
E0HM79WPP211n/aWPP21WPP212025-07-11

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