FDA.reportPublic FDA data

N/A

Primary DI
00841036026028
Brand
N/A
Company
BIOMET MICROFIXATION, INC
Model
06-1130
Catalog number
06-1130
Published
2015-10-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FWNPROSTHESIS, LARYNX (STENTS AND KEELS)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FWNProsthesis, Larynx (Stents And Keels)Ear, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K896667000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K896667000LORENZ STENTWalter Lorenz Surgical, Inc.1990-02-22FWN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841036026028PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841036026028008410360260288410360260280841036026028

GMDN Terms#

Term, Definition table
TermDefinition
Polymeric laryngeal stentA sterile non-bioabsorbable device intended to be implanted in the larynx for the prevention and treatment of laryngeal stenosis and/or chronic aspiration postoperatively. It is typically a hollow, semi-soft moulded device made of a synthetic polymer(s) (e.g., silicone) intended to conform to the endolaryngeal surface. Disposable devices intended to assist implantation may be included.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(904)741-4400FXJAX-ORDERS@ZIMMERBIOMET.COM

Regulatory Flags#

DUNS number
046189866
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888233025140N/A02-290202-29022020-06-26
00888233025157N/A02-290502-29052020-06-26
00888233025164N/A02-310102-31012020-06-26
00888233025171N/A02-310202-31022020-06-26
00888233025188N/A02-310502-31052020-06-26
00888233025195N/A02-311002-31102020-06-26
00888233025201N/A7014-32667014-32662020-06-26
00841036125844ALLOGENIX02-31012015-09-24
00841036125851ALLOGENIX02-31022015-09-24
00841036125868ALLOGENIX02-31052015-09-24
00841036125875ALLOGENIX02-31102015-09-24
00841036181468ALLOGENIX PLUS02-29022015-09-24
00841036181475ALLOGENIX PLUS02-29052015-09-24
00841036019112N/A02-008302-00832017-06-05
00888233028875Pectus Blu (TM)78-880178-88012026-07-23
00888233028882Pectus Blu (TM)78-880278-88022026-07-23
00888233028899Pectus Blu (TM)78-880378-88032026-07-23
00888233086110Pectus Blu (TM)78-005378-00532026-07-23
00888233086127Pectus Blu (TM)78-005578-00552026-07-23
00888233086134Pectus Blu (TM)78-720078-72002026-07-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
14063107101646Rutter StentBoston Medical Products, Inc.FWN2023-02-18
14063107101653Rutter StentBoston Medical Products, Inc.FWN2023-02-18
14063107101660Rutter StentBoston Medical Products, Inc.FWN2023-02-18
14063107101677Rutter StentBoston Medical Products, Inc.FWN2023-02-18
14063107101684Rutter StentBoston Medical Products, Inc.FWN2023-02-18
14063107101691Rutter StentBoston Medical Products, Inc.FWN2023-02-18
14063107101707Rutter StentBoston Medical Products, Inc.FWN2023-02-18
14063107101714Rutter StentBoston Medical Products, Inc.FWN2023-02-18
14063107101721Rutter StentBoston Medical Products, Inc.FWN2023-02-18
14063107101738Rutter StentBoston Medical Products, Inc.FWN2023-02-18
14063107100441Montgomery® Laryngeal StentBoston Medical Products, Inc.FWN2022-09-29
14063107100465Montgomery® Laryngeal StentBoston Medical Products, Inc.FWN2022-09-29
14063107100472Montgomery® Laryngeal StentBoston Medical Products, Inc.FWN2022-09-29
14063107100489Montgomery® Laryngeal StentBoston Medical Products, Inc.FWN2022-09-29
14063107100496Montgomery® Laryngeal KeelBoston Medical Products, Inc.FWN2022-09-29
14063107100502Montgomery® Laryngeal KeelBoston Medical Products, Inc.FWN2022-09-29
14063107100519Montgomery® Laryngeal KeelBoston Medical Products, Inc.FWN2022-09-29
14063107100526Montgomery® Laryngeal KeelBoston Medical Products, Inc.FWN2022-09-29
14063107100533Montgomery® Laryngeal KeelBoston Medical Products, Inc.FWN2022-09-29
14063107100540Montgomery® Laryngeal KeelBoston Medical Products, Inc.FWN2022-09-29
34063107100445Montgomery® Laryngeal StentBoston Medical Products, Inc.FWN2022-09-29
34063107100469Montgomery® Laryngeal StentBoston Medical Products, Inc.FWN2022-09-29
34063107100476Montgomery® Laryngeal StentBoston Medical Products, Inc.FWN2022-09-29
34063107100483Montgomery® Laryngeal StentBoston Medical Products, Inc.FWN2022-09-29
34063107100490Montgomery® Laryngeal KeelBoston Medical Products, Inc.FWN2022-09-29
34063107100506Montgomery® Laryngeal KeelBoston Medical Products, Inc.FWN2022-09-29
34063107100513Montgomery® Laryngeal KeelBoston Medical Products, Inc.FWN2022-09-29
34063107100520Montgomery® Laryngeal KeelBoston Medical Products, Inc.FWN2022-09-29
34063107100537Montgomery® Laryngeal KeelBoston Medical Products, Inc.FWN2022-09-29
34063107100544Montgomery® Laryngeal KeelBoston Medical Products, Inc.FWN2022-09-29