FDA.reportPublic FDA data

RONGEUR

Primary DI
00888118059307
Brand
RONGEUR
Company
KLS-Martin L.P.
Model
37-389-02-07
Device description
CUTTING, ANTRUM, KERRISON, ANGLED UP, 5 X 5 MM JAWS
Published
2018-09-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JZARONGEUR, MASTOID

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JZARongeur, MastoidEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888118059307PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888118059307008881180593078881180593070888118059307

GMDN Terms#

Term, Definition table
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 table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(904)641-7746KLS-UDI-Info@klsmartin.com

Regulatory Flags#

DUNS number
826499238
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888118143037LEVEL ONE THORACIC, STERILE24-015-39-712024-10-08
00888118143044LEVEL ONE THORACIC, STERILE24-015-49-712024-10-08
00888118131782LEVEL ONE EXTREMITY26-066-60-092026-05-25
00888118131799LEVEL ONE EXTREMITY26-066-70-092026-05-25
00888118144928LEVEL ONE EXTREMITY26-950-40-072026-05-25
00888118145284PURE PECTUS24-070-60-092026-05-25
00888118145291PURE PECTUS24-070-62-092026-05-25
00888118150240PURE PECTUSCTM-241-100-012026-05-25
00888118150257PURE PECTUSCTM-241-101-012026-05-25
00888118150264PURE PECTUSCTM-241-200-012026-05-25
00888118150448IXOSCTM-263-100-012026-05-25
00888118150455IXOSCTM-263-101-012026-05-25
00888118150462IXOSCTM-263-202-012026-05-25
00888118150479IXOSCTM-263-202-022026-05-25
00888118150486IXOSCTM-263-202-032026-05-25
00888118150493IXOSCTM-263-202-042026-05-25
00888118150646IPS60-011-42-09-LP2026-05-25
00888118153029L1 STERNALCTM-242-302-012026-05-25
00888118153050IXOSCTM-263-203-012026-05-25
00888118153067IXOSCTM-263-203-022026-05-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00194613114886MSI Precision Specialty InstrumentsMed Saver, Inc.JZA2025-08-01
00190776383602MillenniumAvalign Technologies, Inc.JZA2024-08-20
00190776306991MillenniumAvalign Technologies, Inc.JZA2023-11-16
00190776296902MillenniumAvalign Technologies, Inc.JZA2022-12-12
04046826105389MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJZA2020-09-24
04046826105396MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJZA2020-09-24
04046826105402MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJZA2020-09-24
04046826105419MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJZA2020-09-24
10381780083245Integra®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJZA2018-10-24
00888118059284RONGEURKLS-Martin L.P.JZA2018-09-26
00888118059291RONGEURKLS-Martin L.P.JZA2018-09-26
00888118059314RONGEURKLS-Martin L.P.JZA2018-09-26
00888118057952RONGEURKLS-Martin L.P.JZA2018-09-26
00888118057969RONGEURKLS-Martin L.P.JZA2018-09-26
00888118057976RONGEURKLS-Martin L.P.JZA2018-09-26
10381780076810Integra®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJZA2018-09-17
10381780076827Integra®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJZA2018-09-17
10381780076834Integra®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJZA2018-09-17
10381780076841Integra®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJZA2018-09-17
10381780198154Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJZA2018-03-27
M2743803051Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJZA2018-03-27
10381780445326Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJZA2018-02-05
10381780445333Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJZA2018-02-05
10381780445418Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJZA2018-02-05
10381780445425Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJZA2018-02-05
10381780445432Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJZA2018-02-05
10381780445449Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJZA2018-02-05
H834MH1912300Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJZA2018-02-05
H834MH1912320Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJZA2018-02-05
H834MH198440Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJZA2018-02-05