FDA.report

BEAR

Primary DI
B351B707110
Brand
BEAR
Company
Mytamed, Inc.
Model
7.07.11
Catalog number
7.07.11
Device description
Jansen-Middleton Septum Forceps, Thru-Cutting
Published
2021-01-11
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

Product Codes

CodeName
KBBRongeur, Nasal

Product Code Classifications

CodeDeviceSpecialtyClass
KBBRongeur, NasalEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B351B707110PrimaryHIBCC0

GMDN Terms

TermDefinition
Craniofacial rongeur, reusableA hand-held manual surgical instrument with sharp, scoop-shaped jaws designed for cutting tough tissues (cartilage, sinew) or bone, through a cutting/biting action, during surgery involving the cranium and/or face (e.g., craniotomy, ethmoidectomy, mastoidectomy, rhinoplasty); it is not dedicated to dental surgery. It is typically made of metal and designed to withstand the forces required to bite over tough/hard tissue. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
015903922
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

Primary DIBrandModelCatalogPublished
B351B203020BEAR2.03.022.03.022020-06-10
B351B615050BEAR6.15.056.15.052020-06-10
B351B620120BEAR6.20.126.20.122020-05-28
B351B620130BEAR6.20.136.20.132020-05-28
B351B620140BEAR6.20.146.20.142020-05-28
B351B706270BEAR7.06.277.06.272020-05-12
B351B706280BEAR7.06.287.06.282020-05-12
B351B706290BEAR7.06.297.06.292020-05-12
B351B706300BEAR7.06.307.06.302020-05-12
B351B706310BEAR7.06.317.06.312020-05-12
B351B706320BEAR7.06.327.06.322020-05-12
B351B706340BEAR7.06.347.06.342020-05-12
B351B707260BEAR7.07.267.07.262020-05-12
B351B810100BEAR8.10.108.10.102020-05-19
B351B707270BEAR7.07.277.07.272020-05-12
B351B707290BEAR7.07.297.07.292020-05-12
B351B707300BEAR7.07.307.07.302020-05-12
B351B810050BEAR8.10.058.10.052020-05-19
B351B810060BEAR8.10.068.10.062020-05-19
B351B810070BEAR8.10.078.10.072020-05-19

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